Laborie Medical Technologies Canada ULC

Address:180 International Drive,Portsmouth,NH,03801,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

DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (8) endoscopic injection needle, gastroenterology-urology (FBK) (2)

Premarket Exempt

No Yes

Clear

injeTAK Adjustable Tip Needle 35cm - 00627825000017 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : FBK

Prescription Use : No

Device Count : 1

injeTAK Adjustable Tip Needle 70cm - 00627825000024 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : FBK

Prescription Use : No

Device Count : 1

Pump Tubing Infusion Line - 00627825000031 Catalog Number :

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Infusion Pump Tube Set - 00627825000048 Catalog Number :

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Infusion Pump Tube Set - 00627825000055 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Urodynamics Measurement Tubing - 00627825000062 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Pressure Transmission Tubing - 00627825000079 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

PTTA-C - 00627825000086 Catalog Number :

Device Description : Pressure Transmission Tubing-Clear

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

PTTA-R - 00627825000093 Catalog Number :

Device Description : Pressure Transmission Tubing-Red

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

ITA - 00627825000109 Catalog Number :

Device Description : Infusion tube

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

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