OssiGuide

GUDID 00813954022253

Anorganic Bone Mineral (10cc)

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00813954022253
NIH Device Record Key5ddf034d-d5a9-4ca9-903c-75356648908e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOssiGuide
Version Model NumberPS-OG10
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954022253 [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 Date2017-06-05

On-Brand Devices [OssiGuide]

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

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