VERSA-DIAL(TM) SHOULDER SYSTEM 407222

GUDID 00880304456716

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable
Primary Device ID00880304456716
NIH Device Record Keyc65b2590-07b5-43f1-b287-2f23ce42e0ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERSA-DIAL(TM) SHOULDER SYSTEM
Version Model Number407222
Catalog Number407222
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

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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304456716 [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

[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


[00880304456716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-03-20

On-Brand Devices [VERSA-DIAL(TM) SHOULDER SYSTEM]

00880304462137407201
00880304461581407232
00880304461574407258
00880304461567407234
00880304461550407244
00880304461543407248
00880304461536407254
00880304461529407256
00880304461512407242
00880304461505407236
00880304457386407296
00880304456860407281
00880304456846407280
00880304456778407266
00880304456761407246
00880304456754407268
00880304456747407278
00880304456730407276
00880304456723407224
00880304456716407222
00880304456709407264
00880304456655407298

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