SURGIX MEDICAL LLC

SURGIX MEDICAL LLC

Address:22317 GOSLING RD,Spring,TX,77389,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

Forceps, General & Plastic Surgery (GEN) (5) Scissors, General, Surgical (LRW) (3) Carrier, Ligature (GEJ) (1) Clamp, Vascular (DXC) (1)

Premarket Exempt

No Yes

Clear

Gen2 - 00840343700003 Catalog Number : G2C31242

Device Description : DEBAKEY FORCEPS 2MM TIP 6.25"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700010 Catalog Number : G2C32274

Device Description : POTTS VASCULAR SCISSORS, 5.25"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700027 Catalog Number : G2C32303

Device Description : POTTS TENOTOMY SCISSOR CVD 6"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700034 Catalog Number : G2C35335

Device Description : MICRO FORCEP, ROUND, STR, 0.9MM TIP W/PLATFORM, 7-1/8"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700041 Catalog Number : G2C35337

Device Description : TISSUE FORCEPS, STRAIGHT, W/PLATFORM 1.0x1.6mm tip, 5/34" 15CM

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700058 Catalog Number : G2C41442

Device Description : DEBAKEY SEMB LIGATURE CARRIER 10-1/4"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEJ

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700065 Catalog Number : G2C41444

Device Description : SEMB LIGATURE FORCEPS STRONGLY CURVED JAWS 9-1/2" 24CM

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700072 Catalog Number : G2C43106

Device Description : KAY AORTIC CLAMP JAW 1-3/4" 8"

Device Class : 2

Duns Number: 080402644

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700089 Catalog Number : G2C62262

Device Description : MICRO RING TIP FCP., STR., DIAMOND DUSTED 1MM TIP, 9"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700096 Catalog Number : G2C62297

Device Description : VASCULAR SCISSOR, ROUND HANDLE, 8MM DIAMETER, STR. 6"

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

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