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) (6) PERINEOMETER (HIR) (3) UROFLOWMETER (EXY) (1)

Premarket Exempt

No Yes

Clear

Urocap IV Light - 10627825005965 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : EXY

Prescription Use : No

Device Count : 1

Peritron - 10627825006276 Catalog Number :

Device Description : with Anal Sensor

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Peritron - 10627825006283 Catalog Number :

Device Description : with Vaginal Sensor

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Peritron - 10627825006290 Catalog Number :

Device Description : with Anal and Vaginal Sensor

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

Infusion set for Cavernosometry - 10627825006955 Catalog Number :

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Pump Tube Set for Andromeda - 10627825006962 Catalog Number :

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

8 Ch. Single Use Anorectal Manometry Catheter - 10627825006986 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : FEN

Prescription Use : No

Device Count : 1

4 Ch. Single Use Anorectal Manometry Catheter-Radi - 10627825006993 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : FEN

Prescription Use : No

Device Count : 1

4 Ch. Single Use Anorectal Manometry Catheter-Stag - 10627825007013 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : No

Product Code : FEN

Prescription Use : No

Device Count : 1

Extension Set 2 - 10627825007020 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

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