SONTEC INSTRUMENTS, INC.

Address:7248 SOUTH TUCSON WAY,CENTENNIAL,CO,80112,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

Ligator, Hemorrhoidal (FHN) (6) Clamp, Circumcision (HFX) (2) Instrument, Manual, Surgical, General Use (MDM) (1) Laparoscope, General & Plastic Surgery (GCJ) (1)

Premarket Exempt

No Yes

Clear

MCGIVNEY ALLIS HEMORRHOID FORCEPS - B099508553R0 Catalog Number :

Device Description : MCGIVNEY ALLIS HEMORRHOID FORCEPS ANGLED SHANK/ JAW

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

O-RING HEMORRHOID BAND CUTTER - B0995085560 Catalog Number :

Device Description : O-RING HEMORRHOID BAND CUTTER

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

FORD DIXON LIGATOR - B0995085600 Catalog Number :

Device Description : FORD DIXON LIGATOR WITH LOADING CONE & 100 O-RINGS

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

HEMORRHOIDAL LIGATOR - B0995085610 Catalog Number :

Device Description : SIMPLE STYLE HEMORRHOIDAL LIGATOR WITH LOADING CONE

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

HEMORRHOIDAL SUCTION LIGATOR - B0995085750 Catalog Number :

Device Description : HEMORRHOIDAL SUCTION LIGATOR WITH LOADING CONE UP ANGLED

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

HEMORRHOIDAL SUCTION LIGATOR - B0995085800 Catalog Number :

Device Description : HEMORRHOIDAL SUCTION LIGATOR WITH LOADING CONE DOWN ANGLED

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

HEMORRHOID LIGATOR - B0995085850 Catalog Number :

Device Description : HEMORRHOID LIGATOR SELF-LOADING WITH LOADING CONE STRAIGHT

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

UNIVERSAL ARM WITH TABLE CLAMP - B0995168280 Catalog Number :

Device Description : UNIVERSAL ARM WITH TABLE CLAMP

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

MOGEN CIRCUMCISION CLAMP - B0995403740 Catalog Number :

Device Description : MOGEN CIRCUMCISION CLAMP

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

ZIPSER PENIS CLAMP - B0995403800 Catalog Number :

Device Description : ZIPSER PENIS CLAMP

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

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