DEPUY STYLE CAN GLEN REMR MD SSI005295

GUDID 00889024581074

Biomet Orthopedics, LLC

Medullary canal orthopaedic reamer, rigid
Primary Device ID00889024581074
NIH Device Record Keybe2015af-fcd1-4e78-9aa6-d59ec063a122
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEPUY STYLE CAN GLEN REMR MD
Version Model NumberSSI005295
Catalog NumberSSI005295
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
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024581074 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024581074]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by Biomet Orthopedics, LLC

00887868000324 - SKIN PROTECTOR2020-04-06
00887868000386 - SHEATH2020-04-06
00887868001673 - PARALLEL WIRE / DRILL GUIDE2020-04-06
00887868002212 - GUIDE PIN DEPTH GAUGE2020-04-06
00887868002588 - CENTRAL PIN GUIDE, HANDLE/REPOSITIONER2020-04-06
00887868005886 - SCREW HOLDER SLEEVE2020-04-06
00887868009884 - SCREW HOLDER SLEEVE2020-04-06
00887868023057 - ENTRY PORTAL2020-04-06

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