COMPREHENSIVE SHOULDER 110005287

GUDID 00880304568143

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00880304568143
NIH Device Record Key06d0d7b6-ac90-4585-99a8-6251d4d00365
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE SHOULDER
Version Model Number110005287
Catalog Number110005287
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304568143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PHXshoulder prosthesis, reverse configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304568143]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-15
Device Publish Date2016-10-28

On-Brand Devices [COMPREHENSIVE SHOULDER]

00880304568181110005302
00880304568174110005298
00880304568167110005294
00880304568150110005291
00880304568143110005287
00880304568136110005285
00880304568129110005283
00880304568112110005281
00880304568105110005273
00880304567955110005240
00880304567948110005237
00880304469563595505

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