GPS® III PLATELET CONCENTRATION SYSTEM 800-1007A

GUDID 00880304681514

Biomet Biologics, LLC

Haematological concentrate system
Primary Device ID00880304681514
NIH Device Record Key2bb90f9b-fa03-471d-9d92-4c81b7b8db4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPS® III PLATELET CONCENTRATION SYSTEM
Version Model Number800-1007A
Catalog Number800-1007A
Company DUNS802003074
Company NameBiomet Biologics, LLC
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
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

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304681514 [Primary]
GS170880304681513 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSSSUPPLIES, BLOOD-BANK

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-03

On-Brand Devices [GPS® III PLATELET CONCENTRATION SYSTEM]

00880304681514800-1007A
00880304681507800-1004A
00880304681491800-1003A
00880304641068800-1006A

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