COMPREHENSIVE INSTRUMENTS 010001799

GUDID 00880304539341

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00880304539341
NIH Device Record Key793ee2e3-370f-4998-8dd8-24a45ac3e191
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE INSTRUMENTS
Version Model Number010001799
Catalog Number010001799
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
GS100880304539341 [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

[00880304539341]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-10-26

On-Brand Devices [COMPREHENSIVE INSTRUMENTS]

00880304539433110003472
00880304539426110003483
00880304539419110003478
00880304539402110003476
00880304539396110003474
00880304539389110004265
00880304539372010001791
00880304539365010001800
00880304539358010001801
00880304539341010001799
00880304539334010001790
00880304539327010001792
00880304539310110004200
00880304539303110003486
00880304539280110003488
00880304537781110003484
00880304537026110003489
00880304564381010001789
00880304564374010001788
00880304564367010001787

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