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) (4) Clamp, Vascular (DXC) (1)

Premarket Exempt

No Yes

Clear

HEINE MPACK UNPLUGGED BATTERY - B099X007996660 Catalog Number :

Device Description : HEINE MPACK UNPLUGGED BATTERY WITH MOBILE TRANSFORMER

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE MPACK - B099X007996710 Catalog Number :

Device Description : HEINE MPACK WITH BATTERY

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE MPACK COMPLETE - B099X007996720 Catalog Number :

Device Description : HEINE MPACK COMPLETE WITH TRANSFORMER

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

HEINE LI-ION BATTERY - B099X007996760 Catalog Number :

Device Description : HEINE LI-ION BATTERY FOR MPACK AND MPACK LL

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : HLJ

Prescription Use : Yes

Device Count : 1

DEBAKEY SATINSKY OCCLUSION CLAMP - BO9921007340 Catalog Number :

Device Description : DEBAKEY SATINSKY OCCLUSION CLAMP DOUBLE ANGLED JAW

Device Class : 2

Duns Number: 040729840

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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