Biomet Orthopedics, LLC

Biomet Orthopedics, 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

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY (GEA) (2) Arthroscope (HRX) (1)

Premarket Exempt

No Yes

Clear

AQUALOC® - 08428898894655 Catalog Number : 900367H

Device Class : 1

Duns Number: 129278169

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 6

AQUALOC® - 08428898894662 Catalog Number : 900360

Device Class : 1

Duns Number: 129278169

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 6

4.5MM BARREL ROTOR BUR - 08428898895812 Catalog Number : 908466

Device Class : 2

Duns Number: 129278169

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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