DirectCell Advanced Bone Grafting System BGS-8C-010-AGS

GUDID 00812593021542

Kit Contains: (1) 010-AGS, Medium Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593021542
NIH Device Record Keya4b000d7-4d6c-4665-b105-d1b71883437c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectCell Advanced Bone Grafting System
Version Model NumberBGS-8C-010-AGS
Catalog NumberBGS-8C-010-AGS
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812593021542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-03-04
Device Publish Date2021-02-24

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

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