HYGENIC CORPORATION, THE

Address:Plot 6 Bemban Industrial Park,Batu Gajah Perak,MY

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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

Tourniquet, Nonpneumatic (GAX) (7) Tape And Bandage, Adhesive (KGX) (3)

Premarket Exempt

Yes

Clear

Cramer AT Pro Tape - 00311960003209 Catalog Number :

Device Description : Cramer AT Pro Tape, White 1.5" x 15 yards (32 Rolls)

Device Class : 1

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Cramer AT Pro Tape - 00311960003216 Catalog Number :

Device Description : Cramer AT Pro Tape, White 1.5" x 15 yards Sample Tube

Device Class : 1

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Safer Pain Relief Sales Kit - 00731124001252 Catalog Number :

Device Description : TheraBand Kinesiology Tape Precut Roll- Black/ Gray, Spray, resistance bands, br

Device Class : 1

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Hygenic - 10087453020011 Catalog Number :

Device Description : Latex Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 200

Hygenic - 10087453020028 Catalog Number :

Device Description : Latex Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 250

Hygenic - 10087453021858 Catalog Number :

Device Description : Latex Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 2500

Hygenic - 10087453073468 Catalog Number :

Device Description : Latex Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 100

Hysynal - 10087453102045 Catalog Number :

Device Description : Hysynal Synthetic Rubber Tourniquet Strap, Perforated

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 100

Hysynal - 10087453102632 Catalog Number :

Device Description : Hysynal Synthetic Rubber Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 250

Hysynal - 10087453102649 Catalog Number :

Device Description : Hysynal Synthetic Rubber Tourniquet Strap

Device Class :

Duns Number: 004163390

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 100

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