MODIFIED EXACT OFFSET BROACH HANDLE SSI007713

GUDID 00889024685581

Zimmer, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID00889024685581
NIH Device Record Key567d76ec-1967-455a-94cc-f5045cc8f0b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFIED EXACT OFFSET BROACH HANDLE
Version Model NumberSSI007713
Catalog NumberSSI007713
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024685581 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


[00889024685581]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

Devices Manufactured by Zimmer, Inc.

00889024685581 - MODIFIED EXACT OFFSET BROACH HANDLE2025-03-11
00889024685581 - MODIFIED EXACT OFFSET BROACH HANDLE2025-03-11
00889024687288 - Reusable 3.2mm Pin - 178mm long2025-03-11
00889024687431 - SPRING PLUNGER ASSY, STD2025-03-11
00889024687448 - SPRING PLUNGER ASSY, AGGRESSIVE2025-03-11
00889024658134 - Persona® Knee System2025-02-14
00889024658141 - Persona® Knee System2025-02-14
00889024658158 - Persona® Knee System2025-02-14
00889024658165 - Persona® Knee System2025-02-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.