SPIRUS MEDICAL LLC

Address:375 West St,W Bridgewater,MA,02379,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

Endoscopic Access Overtube, Gastroenterology-Urology (FED) (3) Lubricant, Patient (KMJ) (1)

Premarket Exempt

Clear

Endo-Ease Vista Retrograde - 00867630000202 Catalog Number : EEV-200

Device Description : Endo-Ease Endoluminal Advancement System

Device Class :

Duns Number: 969696975

Premarket Exempt : No

Product Code : FED

Prescription Use : No

Device Count : 1

Endo-Ease Discovery Low Profile - 00867630000219 Catalog Number : EED-250

Device Description : Overtube to aid endoscopic insertion and advancement to the mid-ileum during dia Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.

Device Class :

Duns Number: 969696975

Premarket Exempt : No

Product Code : FED

Prescription Use : No

Device Count : 1

Endo-Ease Discovery Standard Profile - 00867630000226 Catalog Number : EED-300

Device Class :

Duns Number: 969696975

Premarket Exempt : No

Product Code : FED

Prescription Use : No

Device Count : 1

Endo-Ease Lubricant - 00867630000233 Catalog Number : EEL-400

Device Description : A water soluble and intended for medical purposes to lubricate body orifices to A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

Device Class :

Duns Number: 969696975

Premarket Exempt : No

Product Code : KMJ

Prescription Use : No

Device Count : 1

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