IM TIB GDE ARM SSI006549

GUDID 00889024624849

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00889024624849
NIH Device Record Key3d0efbf2-dbee-49c1-9817-064ebaa360c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameIM TIB GDE ARM
Version Model NumberSSI006549
Catalog NumberSSI006549
Company DUNS056038268
Company NameZimmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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
GS100889024624849 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


[00889024624849]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

Devices Manufactured by Zimmer, Inc.

00889024660595 - BIOMET Anterior Adapter2024-04-23
00889024660601 - BIOMET Posterior Adapter2024-04-23
00889024660816 - +9MM Spacer Block C/D 10mm 2024-04-23
00889024660823 - +9MM Spacer Block C/D 12mm 2024-04-23
00889024660830 - +9MM Spacer Block C/D 14mm 2024-04-23
00889024660847 - +9MM Spacer Block C/D 16mm 2024-04-23
00889024660854 - +9MM Spacer Block C/D 18mm 2024-04-23
00889024660861 - +9MM Spacer Block C/D 20mm 2024-04-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.