GPS® III Platelet Concentration System 800-1003A

GUDID 00880304681491

Biomet Biologics, LLC

Haematological concentrate system
Primary Device ID00880304681491
NIH Device Record Keybab7a82b-9d86-42f0-b317-81212c10d955
Commercial Distribution StatusIn Commercial Distribution
Brand NameGPS® III Platelet Concentration System
Version Model Number800-1003A
Catalog Number800-1003A
Company DUNS802003074
Company NameBiomet Biologics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100880304681491 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-14
Device Publish Date2018-11-13

On-Brand Devices [GPS® III Platelet Concentration System]

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

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