COSMO TECHNOLOGIES LIMITED

Address:Riverside II,Dublin 2,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

Submucosal Injection Agent (PLL) (4)

Premarket Exempt

Clear

Eleview - 05391530190015 Catalog Number :

Device Description : A sterile solution intended to be injected via an endoscopic injection needle in A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g. polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. it is typically a gel-like substance containing an emulsion of fats and salts, and may include a dye. This is a single-use device.

Device Class :

Duns Number: 989891457

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 5

Eleview - 05391530190053 Catalog Number :

Device Description : 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sampl 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not for resale.

Device Class :

Duns Number: 989891457

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 2

Eleview - 05391530190367 Catalog Number :

Device Description : 5 Ampoules, 10 mL each. To facilitate endoscopic resection procedures.

Device Class : 2

Duns Number: 989891457

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 5

Eleview 5mL - 05391530190466 Catalog Number :

Device Description : 5 ampoules, 5 mL each. To Facilitate endoscopic resection procedures

Device Class : 2

Duns Number: 989891457

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 5

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