Augmented BP Reamer Guide Extractor SSI008304

GUDID 00889024692794

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00889024692794
NIH Device Record Key1012a227-de2f-4b19-b5eb-1c66d2f082bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAugmented BP Reamer Guide Extractor
Version Model NumberSSI008304
Catalog NumberSSI008304
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

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024692794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024692794]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-26
Device Publish Date2025-12-18

Devices Manufactured by Biomet Orthopedics, LLC

00889024692794 - Augmented BP Reamer Guide Extractor2025-12-26
00889024692794 - Augmented BP Reamer Guide Extractor2025-12-26
00889024703940 - Trocar K-Wire2025-12-26
00889024703926 - Trocar K-Wire2025-12-25
00889024703933 - Trocar K-Wire2025-12-25
00889024703957 - Trocar K-Wire2025-12-25
00889024703223 - Modular Arthrodesis Nail2025-12-17
00889024703247 - Modular Arthrodesis Nail2025-12-17
00889024703278 - OSS™ Orthopedic Salvage System2025-12-17

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