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

Staple, Fixation, Bone (JDR) (8) Kit, Surgical Instrument, Disposable (KDD) (1) Motor, Surgical Instrument, Ac-Powered (GEY) (1)

Premarket Exempt

Clear

OSStaple - 00810633020579 Catalog Number :

Device Description : OSStaple 15X12W2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020586 Catalog Number :

Device Description : OSStaple 20X20 W2X3

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020593 Catalog Number :

Device Description : OSStaple 15X15W2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020609 Catalog Number :

Device Description : OSStaple 09X07W1.2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020623 Catalog Number :

Device Description : OSStaple 18X25W2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Speed - 00810633020630 Catalog Number :

Device Description : Drill Bit Kit used with SHIFT

Device Class : 1

Duns Number: 792619009

Premarket Exempt : No

Product Code : KDD

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020647 Catalog Number :

Device Description : OSStaple 18X18X15W2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020654 Catalog Number :

Device Description : OSStaple 20X20W2

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

OSStaple - 00810633020661 Catalog Number :

Device Description : OSStaple 18X30W2X3

Device Class : 2

Duns Number: 792619009

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

BoneHog - 00810633020692 Catalog Number :

Device Description : BoneHog 6mm Collection Chamber

Device Class : 1

Duns Number: 792619009

Premarket Exempt : No

Product Code : GEY

Prescription Use : Yes

Device Count : 1

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