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) (3) Dislodger, Stone, Basket, Ureteral, Metal (FFL) (2) Electrocautery, Gynecologic (And Accessories) (HGI) (2) Bougie, Urological (FAX) (1) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1) Surgical Instruments, G-U, Manual (And Accessories) (KOA) (1)

Premarket Exempt

No Yes

Clear

Greenwald Surgical Company, Inc. - 10801334000165 Catalog Number : U413

Device Description : Zipser Meatus Clamp

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000172 Catalog Number : U515

Device Description : No-slip tip urethral suture guide

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000196 Catalog Number : C9800-01

Device Description : OLYMPUS ACTIVE CORD W/BOVIE MACHINE PLUG

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000202 Catalog Number : U515

Device Description : No-slip tip urethral suture guide

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000226 Catalog Number : CET107B

Device Description : Flexible bugbee tip electrode for rigid cystoscope. Precision machined nickel/si Flexible bugbee 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. - 10801334000233 Catalog Number : CET107B

Device Class : 2

Duns Number: 607903382

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000240 Catalog Number : U419

Device Description : Otis bougie-a-boule. stainless steel

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FAX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc - 10801334000257 Catalog Number : P66D

Device Description : Smith Endoscopic Handle

Device Class : 2

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000264 Catalog Number : U310R

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. - 10801334000271 Catalog Number : C9402-00

Device Description : FINE NEEDLE ELECT.

Device Class :

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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