Cement Delivery System 110030623

GUDID 70880304810999

BIOMET

Orthopaedic cement dispenser
Primary Device ID70880304810999
NIH Device Record Keyf2e5e52a-69a7-4466-a55f-7df6225869f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCement Delivery System
Version Model Number110030623
Catalog Number110030623
Company DUNS260930126
Company NameBIOMET
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304810990 [Primary]
GS170880304810999 [Unit of Use]

FDA Product Code

KIHDispenser, Cement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

On-Brand Devices [Cement Delivery System]

70880304810999110030623
073500237717194146

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