GRACE MANUFACTURING, INC.

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

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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) Urethrotome (EZO) (2) Clamp, Penile (FHA) (1) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Stylet For Catheter, Gastro-Urology (EZB) (1) Surgical Instruments, G-U, Manual (And Accessories) (KOA) (1)

Premarket Exempt

Yes No

Clear

Greenwald Surgical Company, Inc. - 10801334000875 Catalog Number : SE79B

Device Description : Cutting and coagulating Ball Tip Electrode. Nylon insulation. Fits most popular Cutting and coagulating Ball Tip 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. - 10801334000882 Catalog Number :

Device Description : URETEROSCOPIC GRASPING FORCEPS, 3 WIRE

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000899 Catalog Number : EET107B

Device Description : Bugbee tip electrode for flexible ureteroscopes and flexible cystoscopes. Precis Bugbee tip electrode for flexible ureteroscopes and flexible cystoscopes. 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. - 10801334000905 Catalog Number : U414R

Device Description : Cunningham incontinence clamp, Regular

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FHA

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000929 Catalog Number :

Device Description : Heyman Disposable Nephrostomy Stylet

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : EZB

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000950 Catalog Number : U157VR

Device Description : Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainle Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainless steel Round blade. Distal stabilization for proper alignment with telescope. Compatible with ACMI pre-USA visual urethrotome.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : EZO

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000967 Catalog Number : U157VS

Device Description : Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainle Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainless steel straight blade. Distal stabilization for proper alignment with telescope. Compatible with ACMI pre-USA visual urethrotome.

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : EZO

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000974 Catalog Number : CET107

Device Description : Flexible pointed tip electrode for rigid cystoscope. Precision machined nickel/s Flexible pointed 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. - 10801334000981 Catalog Number : EET107C

Device Description : Domed tip electrode for flexible ureteroscopes and flexible cystoscopes. Precisi Domed tip electrode for flexible ureteroscopes and flexible cystoscopes. 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. - 10801334000998 Catalog Number : CET107

Device Description : Flexible pointed tip electrode for rigid cystoscopes. Precision machined nickel/ Flexible pointed tip electrode for rigid cystoscopes. Precision machined nickel/silver electrode tip

Device Class : 2

Duns Number: 607903382

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

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