BLACK & BLACK SURGICAL, INC.

BLACK & BLACK SURGICAL, INC.

Address:5175 South Royal Atlanta Drive,Tucker,GA,30084,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

LIGHT, SURGICAL HEADLIGHT (EBA) (3) Arthroscope (HRX) (2) ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY (GEG) (1) KNIFE, NASAL (KAS) (1) RETRACTOR (GAD) (1) HOLDER, NEEDLE, GASTROENTEROLOGIC (FHQ) (1) DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY (GDI) (1)

Premarket Exempt

No Yes

Clear

N/A - 00840329800017 Catalog Number : B3B-15-8.2

Device Description : NEEDLE HOLDER, MICRO, 8MM ROUND HANDLE, 6", 15CM, CURVED, W/0 LOCK, 0.2MM TIP

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : Yes

Device Count : 1

N/A - 00840329800024 Catalog Number : B61164

Device Description : US ARMY RETRACTORS; 8 1/2''(21.5CM), SET OF TWO

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

N/A - 00840329800031 Catalog Number : B62400

Device Description : DINGMAN OTOBRADERS; 6''(15CM) - SOLD AS A PAIR ONLY

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : GEG

Prescription Use : Yes

Device Count : 1

N/A - 00840329800048 Catalog Number : B63700

Device Description : AGRIS-DINGMAN STAINLESS STEEL DISSECTORS; 14''(36CM), LEFT & RIGHT (PAIRS ONLY)

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : GDI

Prescription Use : Yes

Device Count : 1

N/A - 00840329800055 Catalog Number : B63885

Device Description : ROSEN CARTILAGE KNIFE; 7 1/2''(19.3CM)

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : KAS

Prescription Use : Yes

Device Count : 1

N/A - 00840329800062 Catalog Number : B65921

Device Description : ENDOPLASTIC SCOPE; 7''(17.5CM), 30 DEGREE, 4MM DIAMETER,

Device Class : 2

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : HRX

Prescription Use : Yes

Device Count : 1

N/A - 00840329800079 Catalog Number : B65922

Device Description : ENDOPLASTIC SCOPE; 7"(18CM), 0 DEGREE, 4MM DIAMETER

Device Class : 2

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : HRX

Prescription Use : Yes

Device Count : 1

N/A - 00840329800086 Catalog Number : B78471

Device Description : ADJUSTABLE VOROTEK LED HEADLIGHT - HEADBAND; 10HR BATTERY PACK, CHARGER, AND CASE

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : EBA

Prescription Use : Yes

Device Count : 1

N/A - 00840329800093 Catalog Number : B78472

Device Description : VOROTEK LED HEADLIGHT - SPECFRAME; 10HR BATTERY PACK, CHARGER, AND CASE

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : EBA

Prescription Use : Yes

Device Count : 1

N/A - 00840329800109 Catalog Number : B78520

Device Description : O SCOPE" TEACHING MIRROR

Device Class : 1

Duns Number: 004382282

Premarket Exempt : Yes

Product Code : EBA

Prescription Use : Yes

Device Count : 1

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