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

Retractor, Non-Self-Retaining (FGN) (5) Ligator, Hemorrhoidal (FHN) (3) Catheter And Tip, Suction (JOL) (1) Elevator, Ent (KAD) (1)

Premarket Exempt

No Yes

Clear

TEBBETTS SUCTION WOUND RETRACTOR - B09946934020 Catalog Number :

Device Description : TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED SMOOTH ROUND EDGE

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FGN

Prescription Use : No

Device Count : 1

TEBBETTS SUCTION WOUND RETRACTOR - B09946934030 Catalog Number :

Device Description : TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED SMOOTH ROUND EDGE

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FGN

Prescription Use : No

Device Count : 1

TEBBETTS SUCTION WOUND RETRACTOR - B09946934040 Catalog Number :

Device Description : TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED SMOOTH ROUND EDGE

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FGN

Prescription Use : No

Device Count : 1

TEBBETTS SUCTION WOUND RETRACTOR - B09946934050 Catalog Number :

Device Description : TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED SMOOTH ROUND EDGE

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FGN

Prescription Use : No

Device Count : 1

TEBBETTS SUCTION WOUND RETRACTOR - B09946934060 Catalog Number :

Device Description : TEBBETTS SUCTION WOUND RETRACTOR ILLUMINATED SMOOTH ROUND EDGE

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FGN

Prescription Use : No

Device Count : 1

DANIEL ENDOSCOPIC FOREHEAD SUCTION ELEVATOR - B0994783700 Catalog Number :

Device Description : DANIEL ENDOSCOPIC FOREHEAD SUCTION ELEVATOR SLIGHT CURVED

Device Class : 1

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : KAD

Prescription Use : Yes

Device Count : 1

BUIE RECTAL SUCTION TUBE - B0995085230 Catalog Number :

Device Description : BUIE RECTAL SUCTION TUBE WITH FINGER VALVE

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 1

MCGIVNEY HEMORRHOIDAL LIGATOR - B0995085500 Catalog Number :

Device Description : MCGIVNEY HEMORRHOIDAL 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

LATEX O-RINGS - B0995085510 Catalog Number :

Device Description : LATEX O-RINGS REGULAR (100 PER BAG)

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

LATEX O-RINGS - B0995085520 Catalog Number :

Device Description : LATEX O-RINGS SMALL (100 PER BAG)

Device Class : 2

Duns Number: 040729840

Premarket Exempt : Yes

Product Code : FHN

Prescription Use : No

Device Count : 1

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