DIVERSATEK HEALTHCARE, INC.

Address:9150 Commerce Center Cir Ste 500,Highlands Ranch,CO,80129,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

Catheter, Irrigation (GBX) (4) Insufflator, Laparoscopic (HIF) (2) Tube, Aspirating, Flexible, Connecting (BYY) (2)

Premarket Exempt

No Yes

Clear

Medovations® - M783SU11140 Catalog Number : SU1114

Device Description : Laparoscopic Insufflation Tubing with Filter

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11220 Catalog Number : SU1122

Device Description : Laparoscopic Insufflation Tubing with 22mm Filter

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11590 Catalog Number : SU1159

Device Description : Liposuction Tubing Tapered

Device Class : 2

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11600 Catalog Number : SU1160

Device Description : Aspiration Tubing

Device Class : 2

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11610 Catalog Number : SU1161

Device Description : Infiltration Y Tubing

Device Class : 1

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11630 Catalog Number : SU1163

Device Description : Infiltration Tubing

Device Class : 1

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU11680 Catalog Number : SU1168

Device Description : Infiltration Tubing for Peristaltic Pumps

Device Class : 1

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Medovations® - M783SU1170LY0 Catalog Number : SU1170LY

Device Description : Bifurcated Tubing

Device Class : 1

Duns Number: 030650113

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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