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

Pick, Microsurgical Ear (JYT) (2) Excavator, Ear (JYH) (1) Forceps, General & Plastic Surgery (GEN) (1) Knife, Ear (JYO) (1) Knife, Ent (KTG) (1) Knife, Surgical (EMF) (1) Needle, Tonsil Suturing (KBR) (1) Curette, Surgical, General Use (FZS) (1) Tape, Measuring, Rulers And Calipers (FTY) (1)

Premarket Exempt

No Yes

Clear

Gen2 - 00840343700409 Catalog Number : G2E17512

Device Description : HOUSE MEASURING ROD, 4.0mm

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700416 Catalog Number : G2E17515

Device Description : HOUSE OVAL WINDOW PICK, 0.66mm

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : JYT

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700423 Catalog Number : G2E17516

Device Description : HOUSE HOUGH EXCAVATOR

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : JYH

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700430 Catalog Number : G2E17517

Device Description : HOUSE OVAL WINDOW PICK, 0.33mm

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : JYT

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700447 Catalog Number : G2E17506

Device Description : PAPARELLA SICKLE KNIFE STR

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : KTG

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700454 Catalog Number : G2E17522

Device Description : HOUSE INCUDO JOINT KNIFE, 0.75

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : EMF

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700461 Catalog Number : G2E17519

Device Description : HOUSE NEEDLE, LIGHT CVD, DULL

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : KBR

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700478 Catalog Number : G2E22686

Device Description : HOUSE LANCET KNIFE

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : JYO

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700485 Catalog Number : G2E38514

Device Description : HOUSE CUP FORCEP ANG DN, 0.6mm

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

Gen2 - 00840343700492 Catalog Number : G2E5591

Device Description : BUCK EAR CURETTE, ANG BLUNT 1.

Device Class : 1

Duns Number: 080402644

Premarket Exempt : Yes

Product Code : FZS

Prescription Use : Yes

Device Count : 1

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