BIOMET 3I, LLC

Address:4555 Riverside Drive,Palm Beach Gardens,FL,33410,US

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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

ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (10)

Premarket Exempt

No Yes

Clear

NA - 00844868000631 Catalog Number :

Device Description : AUTOCLAVABLE ORGANIZER BOX

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000648 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 3.4MM(D) X 4MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000655 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 4.1MM(D) X 5MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000662 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 4.1MM(D) X 6MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000679 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 4.1MM(D) X 7.5MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000686 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 5MM(D) X 5MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000693 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 5MM(D) X 6MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000709 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 5MM(D) X 7.5MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000716 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 6MM(D) X 6MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000723 Catalog Number :

Device Description : BONE PROFILER W/GUIDE PIN 6MM(D) X 7.5MM(P)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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