Bigliani Flatow SSI005084

GUDID 00889024572492

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00889024572492
NIH Device Record Keybb69aa82-b540-4e76-8732-f4cb0098eacd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBigliani Flatow
Version Model NumberSSI005084
Catalog NumberSSI005084
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
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024572492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


[00889024572492]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-06
Device Publish Date2019-04-26

On-Brand Devices [Bigliani Flatow]

00889024575530SSI005199
00889024572492SSI005084

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