GALT MEDICAL CORP.

Address:2220 Merritt Dr,GARLAND,TX,75041,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

Accessories, Catheter (KGZ) (5) Introducer, Catheter (DYB) (5)

Premarket Exempt

No Yes

Clear

Dilator - 00841268100305 Catalog Number : DIL-601-05

Device Description : Dilator

Device Class : 2

Duns Number: 943156836

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Dilator - 00841268100312 Catalog Number : DIL-601-06

Device Description : Dilator

Device Class : 2

Duns Number: 943156836

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Dilator - 00841268100329 Catalog Number : DIL-601-07

Device Description : Dilator

Device Class : 2

Duns Number: 943156836

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Dilator - 00841268100336 Catalog Number : DIL-601-08

Device Description : Dilator

Device Class : 2

Duns Number: 943156836

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Dilator - 00841268100343 Catalog Number : DIL-615-29

Device Description : Dilator

Device Class : 2

Duns Number: 943156836

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Centeze Centesis Catheter - 00841268100350 Catalog Number : DRC-002-01

Device Description : Centeze Centesis Catheter

Device Class :

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Centeze Centesis Catheter - 00841268100367 Catalog Number : DRC-002-02

Device Description : Centeze Centesis Catheter

Device Class : 1

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Centeze Centesis Catheter - 00841268100374 Catalog Number : DRC-002-04

Device Description : Centeze Centesis Catheter

Device Class : 1

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Centeze Centesis Catheter - 00841268100381 Catalog Number : DRC-002-05

Device Description : Centeze Centesis Catheter

Device Class : 1

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Centeze Centesis Catheter - 00841268100398 Catalog Number : DRC-002-06

Device Description : Centeze Centesis Catheter

Device Class : 1

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

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