Comprehensive Modular Hybrid Glenoid SSI000916

GUDID 00880304992818

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable
Primary Device ID00880304992818
NIH Device Record Keyc826005a-c40a-45ef-8fc6-9cbd74665f3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameComprehensive Modular Hybrid Glenoid
Version Model NumberSSI000916
Catalog NumberSSI000916
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304992818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304992818]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-06-19

On-Brand Devices [Comprehensive Modular Hybrid Glenoid]

00880304993310SSI002232
00880304993297SSI002230
00880304993037SSI002231
00880304992818SSI000916
00880304992801SSI001912
00880304992795SSI001911
00880304992788SSI001962
00880304992771SSI001961
00880304992764SSI001960
00880304848337SSI003626

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