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

Ophthalmoscope, Battery-Powered (HLJ) (6) Clamp, Circumcision (HFX) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2)

Premarket Exempt

No Yes

Clear

GREUNSION CIRCUMCISION CLAMP - B0995404010 Catalog Number :

Device Description : GREUNSION CIRCUMCISION CLAMP SIZE 1

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

GREUNSION CIRCUMCISION CLAMP - B0995404020 Catalog Number :

Device Description : GREUNSION CIRCUMCISION CLAMP SIZE 2

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

BI POLAR CABLE - B099CORD10000 Catalog Number :

Device Description : BI POLAR CABLE DISPOSABLE STRAIGHT

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BI POLAR CABLE - B099CORD20000 Catalog Number :

Device Description : BIPOLAR CABLE REUSABLE STRAIGHT

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

HEINE HC 50 CONNECTING CORD - B099X000996670 Catalog Number :

Device Description : HEINE HC 50 CONNECTING CORD

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE - BETA R HANDLE - B099X007993760 Catalog Number :

Device Description : HEINE - BETA R HANDLE WITH LITHIUM ION BATTERY

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE - LITHIUM ION BATTERY - B099X007993810 Catalog Number :

Device Description : HEINE LITHIUM ION BATTERY

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE MPACK MINI - B099X007996500 Catalog Number :

Device Description : HEINE MPACK MINI WITH Li-ION BATTERY AND E4-USB TRANSFORMER

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE MPACK LL BATTERY PACK - B099X007996610 Catalog Number :

Device Description : HEINE MPACK LL BATTERY PACK

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE MPACK UNPLUGGED BATTERY - B099X007996650 Catalog Number :

Device Description : HEINE MPACK UNPLUGGED BATTERY

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

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