Anatomic Shoulder TM Combined System SSI004361

GUDID 00889024509405

Zimmer, Inc.

Glenoid orthopaedic reamer
Primary Device ID00889024509405
NIH Device Record Key6324698e-cbdc-48cc-9046-4959310cd732
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomic Shoulder TM Combined System
Version Model NumberSSI004361
Catalog NumberSSI004361
Company DUNS056038268
Company NameZimmer, Inc.
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 Batchfalse
Serial Numbertrue
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) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024509405 [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

[00889024509405]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-08
Device Publish Date2018-03-26

On-Brand Devices [Anatomic Shoulder TM Combined System]

00889024509405SSI004361
00889024509399SSI004359
00889024509382SSI004358
0088786823123082-0180-119-52
0088786823122382-0180-119-46
0088786823121682-0180-119-40

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