A.M. SURGICAL, INC.

Address:285 MIDDLE COUNTRY RD SUITE 206,SMITHTOWN,NY,11787,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

Pin, Fixation, Smooth (HTY) (8) Arthroscope (HRX) (2)

Premarket Exempt

No Yes

Clear

Secure IM Nail - 00857915007316 Catalog Number :

Device Description : One 35mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007323 Catalog Number :

Device Description : One 40mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007330 Catalog Number :

Device Description : One 45mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007347 Catalog Number :

Device Description : One 50mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007354 Catalog Number :

Device Description : One 55mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007361 Catalog Number :

Device Description : One 60mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007378 Catalog Number :

Device Description : One 65mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007385 Catalog Number :

Device Description : One 70mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Pegasus - 00857915007408 Catalog Number :

Device Description : Pegasus Wireless Endoscopy System - Single Use Arthroscope

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Pegasus - 00857915007415 Catalog Number :

Device Description : Pegasus Wireless Receiver

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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