Duns Number:059517509
Device Description: The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® Sy The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be usedfor the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point ofcare. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handlingcharacteristics. The FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier withinsert and cap and 1 - 50 mL Falcon® tube.
Catalog Number
510357
Brand Name
FIBRINET
Version/Model Number
510357
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 28, 2121
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK120008,BK120009,BK120008,BK120009
Product Code
ORG
Product Code Name
Platelet And Plasma Separator For Bone Graft Handling
Public Device Record Key
545130b9-67b9-4e85-a0d4-65d8e492417a
Public Version Date
July 23, 2020
Public Version Number
2
DI Record Publish Date
June 24, 2019
Package DI Number
30851802007084
Quantity per Package
5
Contains DI Package
10851802007080
Package Discontinue Date
June 28, 2121
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |