INTELLIGENT ENDOSCOPY LLC

Address:4740 Commercial Park Ct Ste 1,Clemmons,NC,27012,US

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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

SNARE, FLEXIBLE (FDI) (1)

Premarket Exempt

No Yes

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SmartBand EMR Kit - 00850261006217 Catalog Number : SBEMRK94

Device Description : The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in t The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract.

Device Class : 2

Duns Number: 046601986

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

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