Biomet Biologics, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SUPPLIES, BLOOD-BANK (KSS) (4) CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (3) Syringe, piston (FMF) (2) Bone marrow collection/transfusion kit (LWE) (1)

Premarket Exempt

No Yes

Clear

Plasmax® Counterbalance - 00880304400092 Catalog Number : 800-0510

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

Plasmax® Plus Counterbalance - 00880304443112 Catalog Number : 800-0512

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

BMA Kit - 00880304451759 Catalog Number : 800-0705

Device Class : 2

Duns Number: 802003074

Premarket Exempt : Yes

Product Code : LWE

Prescription Use : Yes

Device Count : 1

GPS® III - 00880304460645 Catalog Number : 800-0744

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

GPS® III - 00880304460652 Catalog Number : 800-0745

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

Biomet® - 00880304484757 Catalog Number : 800-0270

Device Class : 2

Duns Number: 802003074

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

BIOMET® BIOLOGICS - 00880304508781 Catalog Number : 800-0274

Device Class : 2

Duns Number: 802003074

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

GPS®III Mini Platelet Concentration System - 00880304521513 Catalog Number : 800-0505A

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

Plasmax® Plasma Concentration Kit - 00880304640856 Catalog Number : 800-0516

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : KSS

Prescription Use : Yes

Device Count : 1

BioCUE® - 00880304640917 Catalog Number : 800-0614

Device Class : 1

Duns Number: 802003074

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

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