GRACE MANUFACTURING, INC.

Address:614 SR 247,Russellville,AR,72802,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

Sound, Urethral, Metal Or Plastic (FBX) (4) Clamp, Penile (FHA) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Electrocautery, Gynecologic (And Accessories) (HGI) (1) Electrode, Electrosurgical, Active, Urological (FAS) (1)

Premarket Exempt

No Yes

Clear

Greenwald Surgical Company, Inc. - 10801334000424 Catalog Number : SE79E

Device Description : Cutting and coagulating Fine Needle Electrode. Nylon insulation. Fits most popul Cutting and coagulating Fine Needle Electrode. Nylon insulation. Fits most popular electrosurgical handles.

Device Class :

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000431 Catalog Number : P143

Device Description : Proctoscopic electrode, Bovie Fulgurating

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000448 Catalog Number : U311R

Device Description : Resectoscope Cutting Loop. Compatible with Karl Storz #27040 series adult resectoscopes.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000455 Catalog Number : C8104-01

Device Description : ROUND LOOP ELECT.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000462 Catalog Number :

Device Description : Lefort Urethral Sound

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000479 Catalog Number : U343

Device Description : VanBuren Sound, curved, 1-3/4" nominal bend height. Mirror finish, stainless ste VanBuren Sound, curved, 1-3/4" nominal bend height. Mirror finish, stainless steel, precision machined.

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000486 Catalog Number : U340

Device Description : McCrea Female Sound, Curved. 3/4-inch nominal bend height. Mirror finish, stainl McCrea Female Sound, Curved. 3/4-inch nominal bend height. Mirror finish, stainless steel, precision machined.

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000547 Catalog Number :

Device Description : Lefort Urethral Sound

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000561 Catalog Number : U415

Device Description : Baumrucker incontinence clamp

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000592 Catalog Number :

Device Description : Cunningham incontinence clamp, Large

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : Yes

Device Count : 1

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