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

Clip, Scalp (HBO) (8) Drills, Burrs, Trephines & Accessories (Compound, Powered) (HBF) (2)

Premarket Exempt

No Yes

Clear

Disposable Cranial Perforator - 00810607000118 Catalog Number : 200-500 SDR

Device Description : Cranial Perforator

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBF

Prescription Use : No

Device Count : 1

Disposable Cranial Perforator - 00810607000125 Catalog Number : 210-221 CDM

Device Description : Cranial Perforator

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBF

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000132 Catalog Number : 500-103

Device Description : Straight Edge, Heavy Force,Adult Scalp Clip, Two 15 Clip Cartridges

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000149 Catalog Number : 500-104

Device Description : Serrated Edge,Light Force,Pediatric Scalp Clip, Two 15 Clip Cartridges

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000156 Catalog Number : 500-105

Device Description : Serrated Edge,Medium Force,Adult Scalp Clip, Two 15 Clip Cartridges

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000163 Catalog Number : 500-106

Device Description : Serrated Edge,Heavy Force,Adult Scalp Clip, Two 15 Clip Cartridges

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000170 Catalog Number : 500-108

Device Description : Straight Edge, Medium 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

Acra Clip - 00810607000187 Catalog Number : 500-109

Device Description : Straight 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

Acra Clip - 00810607000194 Catalog Number : 500-110

Device Description : Serrated Edge,Light Force,Pediatric Scalp Clip, One 15 Clip Cartridge

Device Class : 2

Duns Number: 612611459

Premarket Exempt : No

Product Code : HBO

Prescription Use : No

Device Count : 1

Acra Clip - 00810607000200 Catalog Number : 500-111

Device Description : Serrated Edge,Medium 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

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