COMP REVRS 1 PC RESECT GUIDE ASSY SSI005290

GUDID 00889024581098

Biomet Orthopedics, LLC

Surgical drill guide, reusable
Primary Device ID00889024581098
NIH Device Record Keyff639237-0db1-4215-b10b-a30b2f7126e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMP REVRS 1 PC RESECT GUIDE ASSY
Version Model NumberSSI005290
Catalog NumberSSI005290
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 Identifiers

Device Issuing AgencyDevice ID
GS100889024581098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024581098]

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

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