ARGON MEDICAL DEVICES, INC.

Address:1445 FLAT CREEK RD.,ATHENS,TX,75751,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, Continuous Irrigation (GBQ) (7) Catheter, Nephrostomy, General & Plastic Surgery (GBO) (3)

Premarket Exempt

No Yes

Clear

SKATER™ Drainage Catheter - 00886333001194 Catalog Number : 755114025

Device Description : SKATER™ Drainage Catheter - locking pigtail 14F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Drainage Catheter - 00886333001200 Catalog Number : 755114035

Device Description : SKATER™ Drainage Catheter - locking pigtail 14F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Drainage Catheter - 00886333001217 Catalog Number : 755116025

Device Description : SKATER™ Drainage Catheter - locking pigtail 16F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001224 Catalog Number : 755514025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 14F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001231 Catalog Number : 755514035

Device Description : Skater™ Nephrostomy Catheter Non-Locking 14F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001248 Catalog Number : 755614025

Device Description : Skater™ Nephrostomy Catheter Locking Pigtail 14Fr x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Single Step Drainage Set - 00886333001262 Catalog Number : 756008030

Device Description : Skater™ Single Step Drainage Set 8Fr x 30cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

Skater™ Single Step Drainage Set - 00886333001279 Catalog Number : 756010030

Device Description : Skater™ Single Step Drainage Set 10Fr x 30cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage - 00886333001286 Catalog Number : 756014020

Device Description : SKATER™ Single Step Drainage Set 14F x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333001309 Catalog Number : 756016025

Device Description : SKATER™ Single Step Drainage Set 16F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

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