ACRA-CUT INC

Address:989 MAIN ST.,ACTON,MA,01720,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

Instrument, Surgical, Disposable (KDC) (8) Clip, Scalp (HBO) (1)

Premarket Exempt

No Yes

Clear

Acra Clip - 00810607000217 Catalog Number : 500-112

Device Description : Serrated Edge,Heavy Force,Adult Scalp Clip, One 15 Clip Cartridge

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000224 Catalog Number : 800-499

Device Description : Distraction Screws Caspar type

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000231 Catalog Number : 800-499x

Device Description : Distraction Screws Caspar type Quantity 10 DI 810607000224

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screw Caspar type - 00810607000248 Catalog Number : 800-500

Device Description : Distraction Screw Caspar type

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000255 Catalog Number : 800-500x

Device Description : Distraction Screws Caspar type Quantity 10 DI 810607000248

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000262 Catalog Number : 800-501

Device Description : Distraction Screws Caspar type

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000279 Catalog Number : 800-501x

Device Description : Distraction Screws Caspar type Quantity 10 DI 810607000262

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000286 Catalog Number : 800-502

Device Description : Distraction Screws Caspar type

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Distraction Screws Caspar type - 00810607000293 Catalog Number : 800-502x

Device Description : Distraction Screws Caspar type Quantity 10 DI 810607000286

Device Class : 1

Duns Number: 612611459

Premarket Exempt : Yes

Product Code : KDC

Prescription Use : No

Device Count : 1

Cranitomy Kit Disposable Low Speed - 00810607000309 Catalog Number : 400-101

Device Description : Cranitomy Kit Consisting of Qty 1 - DI 810607000019 Cranial Perforator Catalog# Cranitomy Kit Consisting of Qty 1 - DI 810607000019 Cranial Perforator Catalog# 200-241, QTY 1 - DI 810607000408 Cranial Blade Catalog# 800-140 & QTY 1 -DI 810607000422 Wire Pass Drill Catalog# 800-330.

Device Class :

Duns Number: 612611459

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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