StaGraft DBM Paste 92-2022

GUDID 00880304706408

Demineralized Bone Matrix (DBM) in a Lipid Carrier

Biomet Orthopedics, LLC

Bone matrix implant, human-derived
Primary Device ID00880304706408
NIH Device Record Keye43a63ab-39b0-4e5f-991e-fb6b1e60bf26
Commercial Distribution StatusIn Commercial Distribution
Brand NameStaGraft DBM Paste
Version Model Number92-2022
Catalog Number92-2022
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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

Customer Support Contacts

Phone1-800-348-9500
Emailcustomerservice@biomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304706408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXPMethyl Methacrylate For Cranioplasty

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 Date2015-10-24

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00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
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