FINE SURGICAL INSTRUMENTS INC.

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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

CLAMP (HXD) (4) CLAMP, CIRCUMCISION (HFX) (4)

Premarket Exempt

Clear

Gomco Type Circumcision Clamp - 00869401000206 Catalog Number : 28-854

Device Description : Gomco Type Circumcision Clamp Disposable Chrome Plated, XSML 1.1cm

Device Class : 2

Duns Number: 103669727

Premarket Exempt : No

Product Code : HFX

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000213 Catalog Number : 28-855

Device Description : Gomco Type Circumcision Clamp Disposable Chrome Plated, NB 1.3cm

Device Class : 2

Duns Number: 103669727

Premarket Exempt : No

Product Code : HFX

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000220 Catalog Number : 28-856

Device Description : Gomco Type Circumcision Clamp Disposable Chrome Plated , Infant 1.45cm

Device Class : 2

Duns Number: 103669727

Premarket Exempt : No

Product Code : HFX

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000237 Catalog Number : 28-857

Device Description : Gomco Type Circumcision Clamp Disposable Chrome Plated, Child 1.6cm

Device Class : 2

Duns Number: 103669727

Premarket Exempt : No

Product Code : HFX

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000244 Catalog Number : 903-014

Device Description : Gomco Type Circumcision Clamp Stainless Steel (German) XSML 1.1cm

Device Class : 1

Duns Number: 103669727

Premarket Exempt : No

Product Code : HXD

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000251 Catalog Number : 903-016

Device Description : Gomco Type Circumcision Clamp Stainless Steel (German) NB 1.3cm

Device Class : 1

Duns Number: 103669727

Premarket Exempt : No

Product Code : HXD

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000268 Catalog Number : 903-018

Device Description : Gomco Type Circumcision Clamp Stainless Steel (German) Infant 1.45cm

Device Class : 1

Duns Number: 103669727

Premarket Exempt : No

Product Code : HXD

Prescription Use : No

Device Count : 1

Gomco Type Circumcision Clamp - 00869401000275 Catalog Number : 903-020

Device Description : Gomco Type Circumcision Clamp Stainless Steel (German) Child 1.6cm

Device Class : 1

Duns Number: 103669727

Premarket Exempt : No

Product Code : HXD

Prescription Use : No

Device Count : 1

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