{"id":11392,"date":"2023-08-16T03:51:33","date_gmt":"2023-08-16T03:51:33","guid":{"rendered":"https:\/\/renovobioscience.com\/dev\/?page_id=11392"},"modified":"2023-11-20T01:41:18","modified_gmt":"2023-11-20T01:41:18","slug":"intra-site","status":"publish","type":"page","link":"https:\/\/renovobioscience.com\/dev\/intra-site\/","title":{"rendered":"Intra-Site"},"content":{"rendered":"
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INTRA-SITE\u00ae<\/span><\/span><\/div>
Connective Tissue Allograft<\/span><\/span><\/div><\/div><\/div>
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INTRA-SITE\u00ae<\/span><\/span><\/div>
Connective Tissue Allograft<\/span><\/span><\/div>
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Intra-Site\u00ae<\/sup><\/span> is a human cell and tissue product (HCT\/P). It is a connective tissue allograft derived from perinatal tissue. The product is regulated by the U.S. FDA under 21 CFR 1271.<\/p>\n<\/div><\/div><\/div><\/div>

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SHOP INTRA-SITE\u00ae<\/sup><\/span><\/h3>\n<\/div><\/div>
SHOP NOW<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Intended Use<\/b><\/h3>\n

Intra-Site\u00ae<\/sup><\/span> is derived from placental connective tissue and is intended for homologous use to supplement or support damaged or inadequate connective tissue in the recipient.<\/p>\n

Storage<\/b><\/h3>\n

Intra-Site\u00ae<\/sup><\/span> has been terminally sterilized and the vial of allograft material is sealed and packaged in double Tyvek\u2122 pouches. The product should be stored between -4 degrees and +40 degrees Celsius. It is the responsibility of the distributors, tissue dispensing services, and\/or clinicians to safely store the allograft in an appropriate location to maintain the shelf-life of the allograft. The allograft is marked with an expiration date and should be used before the end of the shelf-life date.<\/p>\n

Preparations for Use<\/b><\/h3>\n
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  1. Thoroughly examine the outer Tyvek\u2122 pouches to ensure the integrity of the sterile packaging. Do not use the product if the pouch as been compromised.<\/li>\n
  2. Carefully open the outer Tyvek\u2122 pouch allowing access to the inside sterile pouch. (Please do not place the outer pouch on the sterile field.)<\/li>\n
  3. Using appropriate aseptic technique, open the outer pouch and deliver the inner pouch containing the sterile vial to the sterile field.<\/li>\n
  4. Remove the vial from the sterile inner pouch and place in the sterile field.<\/li>\n
  5. In advance of opening the vial, vigorously shake it to ensure that the allograft is well mixed. Twist off the vial cap and draw the allograft material with an appropriately sized sterile needle into a sterile syringe.<\/li>\n
  6. Place the allograft into the desired recipient site.<\/li>\n
  7. Allograft material should be used within 1 hour of opening the sterile vial. Otherwise, the allograft should be discarded.<\/li>\n<\/ol>\n

    Donor Screening <\/b><\/h3>\n

    The allograft material in the Intra-Site\u00ae<\/sup><\/span> product is derived from donated tissue from healthy human donors. The allograft has been determined eligible for transplant by the manufacturer\u2019s Medical Director after review of medical and social history, hospital records, infectious disease screening and testing. The donor was tested and found negative or non-reactive to all standard infectious diseases and contaminations. Testing has been completed by an FDA registered third-party laboratory in accordance with the Clinical Laboratory Improvement Amendment (CLIA) of 1988 and 42 CFR part 493 or has met the equivalent requirements as determined by the Centers of Medicare and Medicaid Services (CMS).<\/p>\n

    Warning and Precautions<\/b><\/h3>\n