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, Nephrostomy, General & Plastic Surgery (GBO) (9) Wire, Guide, Catheter (DQX) (1)

Premarket Exempt

No Yes

Clear

POINTER™ Nitinol Guidewire - 00886333000753 Catalog Number : 180418300

Device Description : POINTER™ Nitinol Guidewire 0.018"/300cm/40mm

Device Class : 2

Duns Number: 140727624

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333000968 Catalog Number : 755506025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 6F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333000975 Catalog Number : 755506035

Device Description : Skater™ Nephrostomy Catheter Non-Locking 6F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333000982 Catalog Number : 755507025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 7F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333000999 Catalog Number : 755507035

Device Description : Skater™ Nephrostomy Catheter Non-Locking 7F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001002 Catalog Number : 755508025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 8F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001019 Catalog Number : 755508035

Device Description : Skater™ Nephrostomy Catheter Non-Locking 8F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001026 Catalog Number : 755510025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 10F x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001033 Catalog Number : 755510035

Device Description : Skater™ Nephrostomy Catheter Non-Locking 10F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

Skater™ Nephrostomy Catheter - 00886333001040 Catalog Number : 755512025

Device Description : Skater™ Nephrostomy Catheter Non-Locking 12Fr x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBO

Prescription Use : Yes

Device Count : 1

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