amdrop™ product benefits1271 and section 361 of the phs. human immunodeficiency virus (hiv) hiv...

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Product Description AmDrop™ is an amniotic liquid allograft derived from the amniotic components of the placenta to advance soft tissue repair, replacement, and reconstruction. It is classified as minimally manipulated under FDA regulation 21 CFR Part 1271 and section 361 of the PHS. Relevant Conditions • Sports Injuries • Joint pain • Tendonitis • Fasciitis • Muscle & Meniscus tears • Wound Care Donor/Tissue Screening The donor of the enclosed DONATED HUMAN TISSUE has been deemed free from risk factors for, and clinical evidence of, infection due to relevant communicable diseases and other exclusionary disease conditions through the review of the donor’s medical records, including medical/behavior risk assessment and a recent physical examination. AmDrop™ Product Benefits Ready to use AmDrop™ is provided in a vial as a ready to use flowable graft, with no thawing or prep required. Room Temperature or Cryopreserved AmDrop™ is stored at room temperature (50-86°F/10-30°C) or cryopreserved until ready for use. Product has a 1-year shelf life. Easy to Apply AmDrop™ is provided in an easy to apply flowable form, for precise delivery. Available in 0.5 cc and 1.0 cc doses. To order, visit amdrop.com or call (267)255-6700 Tel: 1-855-4-AMDROP www.Amdrop.com 14980 Limestone School Rd. Leesburg, VA 20176

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Page 1: AmDrop™ Product Benefits1271 and section 361 of the PHS. HUMAN IMMUNODEFICIENCY VIRUS (HIV) HIV 1/2 Antibodies Nucleic Acid Test for HIV RNA Ready to Use AmDrop™ is provided in

Product DescriptionAmDrop™ is an amniotic liquid allograft derived from the amniotic components of the placenta to advance soft tissue repair, replacement, and reconstruction. It is classified as minimally manipulated under FDA regulation21 CFR Part 1271 and section 361 of the PHS.

Relevant Conditions• Sports Injuries• Joint pain• Tendonitis• Fasciitis• Muscle & Meniscus tears• Wound Care

Donor/Tissue ScreeningThe donor of the enclosed DONATED HUMAN TISSUE has been deemed free from risk factors for, and clinical evidence of, infection due to relevant communicable diseases and other exclusionary disease conditions through the review of the donor’s medical records, including medical/behavior risk assessment and arecent physical examination.

AmDrop™ Product Benefits

Ready to use AmDrop™ is provided in a vial as a ready to use flowable graft, with no thawing or prep required.

Room Temperature or Cryopreserved AmDrop™ is stored at room temperature (50-86°F/10-30°C) or cryopreserved until ready for use. Product has a 1-year shelf life.

Easy to Apply AmDrop™ is provided in an easy to apply flowable form, for precise delivery.

Available in 0.5 cc and 1.0 cc doses.

To order, visit amdrop.comor call (267)255-6700

Tel: 1-855-4-AMDROP www.Amdrop.com14980 Limestone School Rd. Leesburg, VA 20176

Page 2: AmDrop™ Product Benefits1271 and section 361 of the PHS. HUMAN IMMUNODEFICIENCY VIRUS (HIV) HIV 1/2 Antibodies Nucleic Acid Test for HIV RNA Ready to Use AmDrop™ is provided in

Tel: 1-855-4-AMDROP www.Amdrop.com14980 Limestone School Rd. Leesburg, VA 20176

AmDrop™ is an amniotic liquid allograft derived from the amniotic components of the placenta to advance soft tide repair, replacement and reconstruction. It is classified as minimally manipulated under FDA Regulation 21 CFR part 1271 and section 361 of the PHS.

HUMAN IMMUNODEFICIENCY VIRUS (HIV)HIV 1/2 AntibodiesNucleic Acid Test for HIV RNA

Ready to UseAmDrop™ is provided in a vial as a ready to use flowable graft with no thawing or prep required

Room TemperatureAmDrop™ is soured at room temperature (50-86 degree F/10-30 Degrees C) until ready for use. Product has a one year shelf life.

Immuno SuppressiveAmDrop™ has shown to suppress immune response and modulate inflammation.

SterileAmDrop™ is provided in a sterile vial within a peel pouch which may be introduced to a sterile field.

AmDrop™ is donated human tissue and is deemed free from risk factors for and the clinical evidence of infection due to relevant communicable diseases and other exclusionary disease conditions through the review of the donor’s medical records, including medical/behavior risk assessment and a recent physical examination.

AmDrop™ Product Benefits:

Product Description:

Donor/Tissue Screening

HEPATITUS B VIRUS (HBV)HBV Surface AntigenHBV Core Antibody (Total)Nucleic Acid Test for HBV DNA

HEPITITUS C VIRUSHCV AntibodyNucleic Acid Test of HCV RNA

HUMAN T CELL LYMPHOTROPHIC VIRUS I/IIHTLV I/II Antibody

SYPHILISRapid Plasma Reagin Screen*, orTreponemal Specific Test

WEST NILE VIRUSNucleic Acid Test for WNV RNA**

Growth Factor ContentTIMP-1. TIMP-2. VEGFTGF-ß1 TGFß2.TGF-ß3IL-4

PIGFKGFEGFbFGF PDGF-AAPDGF-BB

The donor is deemed eligible for tissue donation by the tissue bank’s Medical Director and has been determined to be acceptable for transplantation use through a stringent quality assurance review process. Additionally, testing of a qualified blood samples indicates that the donor is negative or nonreactive for the following communicable diseases: