Biomedical Enterprises, Inc.

Biomedical Enterprises, Inc.

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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

Pin, Fixation, Smooth (HTY) (8) Staple, Fixation, Bone (JDR) (2)

Premarket Exempt

No

Clear

HammerLock - 00810633020005 Catalog Number :

Device Description : Medium, 19mm length Nitinol Intramedullary Implant

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020012 Catalog Number :

Device Description : Hammerlock implant for DIP

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020029 Catalog Number :

Device Description : Hammerlock X-Type Large

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020036 Catalog Number :

Device Description : Hammerlock Angled X-Type Large

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020043 Catalog Number :

Device Description : Hammerlock Angled X-Type Medium 19

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020050 Catalog Number :

Device Description : Hammerlock X-Type Petite

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020067 Catalog Number :

Device Description : Hammerlock X-Type Small

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HammerLock - 00810633020074 Catalog Number :

Device Description : Hammerlock Angled X-Type Small 16mm

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Speed - 00810633020173 Catalog Number :

Device Description : SPEED 15X15X15mm implant

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020180 Catalog Number :

Device Description : SPEED 18X15X15mm implant

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

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