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

Bougie, Urological (FAX) (3) Electrode, Electrosurgical, Active, Urological (FAS) (3) Sound, Urethral, Metal Or Plastic (FBX) (2) 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. - 10801334000752 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. - 10801334000769 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. - 10801334000776 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. - 10801334000783 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. - 10801334000790 Catalog Number :

Device Description : Heyman Disposable Nephrostomy Stylet, Curved

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : EZB

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000806 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. - 10801334000837 Catalog Number :

Device Description : Walther female Dilator

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000844 Catalog Number : U420

Device Description : Friedman-Otis Bougie-a-Boule, with 3 (graduated) olive tips on one stem. Mirror Friedman-Otis Bougie-a-Boule, with 3 (graduated) olive tips on one stem. Mirror finish, stainless steel, precision machined.

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FAX

Prescription Use : Yes

Device Count : 1

Greenwald Surgical Company, Inc. - 10801334000851 Catalog Number : U420

Device Description : Friedman-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. - 10801334000868 Catalog Number : U420

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

Device Class : 1

Duns Number: 607903382

Premarket Exempt : Yes

Product Code : FAX

Prescription Use : Yes

Device Count : 1

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