KDL MEDICAL, INC.

Address:885 E Collins Blvd Ste 110,RICHARDSON,TX,75081,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

Stabilizer,Heart (MWS) (7) Instruments, Surgical, Cardiovascular (DWS) (3)

Premarket Exempt

No Yes

Clear

FasTract Modified Sternal Retractor, Deep Blades - 00899054002401 Catalog Number :

Device Description : Sternal Retractor, Modified Deep Blades, Reusable

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : No

Device Count : 1

FasTract Suture Stay - 00899054002418 Catalog Number :

Device Description : Sternal Retractor Suture Stays (Single)

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : No

Device Count : 1

FasTract Suture Stays - 00899054002425 Catalog Number :

Device Description : Sternal Retractor Suture Stays (Pair)

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer Med Mtl FasTract - 00899054002432 Catalog Number :

Device Description : Heart Stabilizer, Medium Metal Textured Feet

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer-Nylon Fastract - 00899054002449 Catalog Number :

Device Description : Heart Stabilizer, Nylon Textured Feet

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Stabilizer-Nylon Fastract +2cm - 00899054002456 Catalog Number :

Device Description : Heart Stabilizer, Nylon Textured Feet + 2cm

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer- Lt Mtl Fastract - 00899054002463 Catalog Number :

Device Description : Heart Stabilizer, Light Metal Textured Feet

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Stabilizer- Lt Mtl Fastract +2cm - 00899054002470 Catalog Number :

Device Description : Heart Stabilizer, Light Metal Textured Feet + 2cm

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

Viper I Heart Stabilizer - 00899054002487 Catalog Number :

Device Description : Heart Stabilizer, Vacuum, C Base

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

Viper II Heart Stabilizer - 00899054002494 Catalog Number :

Device Description : Heart Stabilizer, Vacuum, M Base

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

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