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

Electrode, Electrosurgical, Active, Urological (FAS) (4) Sound, Urethral, Metal Or Plastic (FBX) (2) Clamp, Penile (FHA) (1) Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) (HIN) (1) Electrocautery, Gynecologic (And Accessories) (HGI) (1) Stylet For Catheter, Gastro-Urology (EZB) (1)

Premarket Exempt

Yes No

Clear

Greenwald Surgical Company, Inc. - 10801334000608 Catalog Number : U315R

Device Description : Resectoscope Cutting Loop. Compatible with Karl Storz #27050 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. - 10801334000622 Catalog Number :

Device Description : McCrea Female Sound

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FBX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000646 Catalog Number :

Device Description : VanBuren Catheter Stylet

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : EZB

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000677 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. - 10801334000691 Catalog Number : RET107K

Device Description : Ball Tip Electrode for rigid Cystoscopes.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000707 Catalog Number : U332R

Device Description : ACMI Stab. Resectoscope Cutting Loop.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000714 Catalog Number : CET107K

Device Description : Flexible ball tip electrode for rigid cystoscope. Precision machined nickel/silv Flexible ball tip electrode for rigid cystoscope. Precision machined nickel/silver electrode tip.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000721 Catalog Number : C9115-00

Device Description : LAPAROSCOPIC CORD W/BOVIE PLUG

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000738 Catalog Number : C9300-00

Device Description : INSTRUMENT CONNECTOR

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : HIN

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000745 Catalog Number :

Device Description : Cunningham incontinence clamp, Regular

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : Yes

Device Count : 1

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