LAKE REGION MEDICAL LIMITED

Address:BUTLERSLAND,NEW ROSS Wexford,IE

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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

Wire, Guide, Catheter (DQX) (9) Endoscopic Guidewire, Gastroenterology-Urology (OCY) (1)

Premarket Exempt

Yes No

Clear

Starter™ Guidewire - 08714729201328 Catalog Number : 49-145

Device Description : Bentson Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Wallstent - 08714729203070 Catalog Number : H965180011

Device Description : WALLSTENT SS guidewire .035" B/5

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : OCY

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326458 Catalog Number : 49-100

Device Description : Straight Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326465 Catalog Number : 49-102

Device Description : Straight Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326472 Catalog Number : 49-103

Device Description : Straight Moveable Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326489 Catalog Number : 49-111

Device Description : "J" Curved Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326496 Catalog Number : 49-115

Device Description : "J" Curved Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326502 Catalog Number : 49-116

Device Description : "J" Curved Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326519 Catalog Number : 49-117

Device Description : "J" Curved Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Starter™ Guidewire - 08714729326526 Catalog Number : 49-119

Device Description : "J" Curved Fixed Core Guidewire

Device Class : 2

Duns Number: 988555595

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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