DirectCell Advanced Bone Grafting System BGS-8C-003-AGL

GUDID 00812593020576

Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit

BIOGENNIX LLC

Synthetic bone graft
Primary Device ID00812593020576
NIH Device Record Key03ce89fe-d858-4dc7-ae4b-e5883c9e1b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirectCell Advanced Bone Grafting System
Version Model NumberBGS-8C-003-AGL
Catalog NumberBGS-8C-003-AGL
Company DUNS021486533
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
GS100812593020576 [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 Date2020-08-26
Device Publish Date2020-08-18

On-Brand Devices [DirectCell Advanced Bone Grafting System]

00812593020590Kit Contains: (1) 012-AGL, 12cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCell
00812593020583Kit Contains: (1) 006-AGL, 6cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellu
00812593020576Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellu
00812593020477Kit Contains: (1) 012-MOR, 12cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution B
00812593020460Kit Contains: (1) 006-MOR, 6cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bo
00812593020453Kit Contains: (1) 003-MOR, 3cc Morpheus Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bo

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