OssiGuide

GUDID 00813954020297

Anorganic Bone Mineral

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00813954020297
NIH Device Record Key1d2abac0-dc2c-4485-86c0-ad4d304f418e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOssiGuide
Version Model NumberOG05
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100813954020297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

On-Brand Devices [OssiGuide]

00813954022253Anorganic Bone Mineral (10cc)
00813954022246Anorganic Bone Mineral (5cc)
00813954020303Anorganic Bone Mineral
00813954020297Anorganic Bone Mineral

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