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

Percutaneous Sheath Introducer Kit (OFL) (4) Wire, Guide, Catheter (DQX) (3) Accessories, Catheter (KGZ) (2) Instruments, Surgical, Cardiovascular (DWS) (1)

Premarket Exempt

No Yes

Clear

Centeze Centesis Catheter - 00841268100404 Catalog Number : DRC-002-07

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 - 00841268100411 Catalog Number : DRC-002-08

Device Description : Centeze Centesis Catheter

Device Class : 1

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Needle - 00841268100428 Catalog Number : NDL-108-00

Device Description : Needle

Device Class :

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Guidewire - 00841268100435 Catalog Number : SGW-061-15

Device Description : Guidewire

Device Class :

Duns Number: 943156836

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Micro-Access Catheter Introducer Set - 00841268100442 Catalog Number : CLI-129-04

Device Description : Micro-Access Catheter Introducer Set

Device Class : 2

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Micro-Access Catheter Introducer Set - 00841268100459 Catalog Number : CLI-129-06

Device Description : Micro-Access Catheter Introducer Set

Device Class : 2

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Micro-Access Catheter Introducer Set - 00841268100466 Catalog Number : CLI-130-04

Device Description : Micro-Access Catheter Introducer Set

Device Class : 2

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Micro-Access Catheter Introducer Set - 00841268100473 Catalog Number : CLI-130-06

Device Description : Micro-Access Catheter Introducer Set

Device Class : 2

Duns Number: 943156836

Premarket Exempt : Yes

Product Code : OFL

Prescription Use : Yes

Device Count : 1

Guidewire - 00841268100480 Catalog Number : USEGS14-300A

Device Description : Guidewire

Device Class :

Duns Number: 943156836

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Guidewire - 00841268100497 Catalog Number : USEGS18-300A

Device Description : Guidewire

Device Class :

Duns Number: 943156836

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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