DirectCell Advanced Bone Grafting System BGS-8C-001-AGL

GUDID 00812593021573

Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593021573
NIH Device Record Keyf1e0f3da-0058-4515-9737-194ede27e04c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectCell Advanced Bone Grafting System
Version Model NumberBGS-8C-001-AGL
Catalog NumberBGS-8C-001-AGL
Company DUNS832270370
Company NameBiogennix, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812593021573 [Primary]

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-25
Device Publish Date2022-04-15

On-Brand Devices [DirectCell Advanced Bone Grafting System]

00812593021559Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellu
00812593021542Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cell
00812593021573Kit Contains: (1) 001-AGL, 1.5cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.