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) (6) Ligator, esophageal (MND) (4) Ligator, hemorrhoidal (FHN) (4)

Premarket Exempt

No Yes

Clear

SmartBand Ligation Pack - 00850261006002 Catalog Number : IE11001

Device Description : Multi-Band Ligation Pack

Device Class : 2

Duns Number: 046601986

Premarket Exempt : Yes

Product Code : FHN, MND

Prescription Use : Yes

Device Count : 1

SmartBand Ligation Kit - 00850261006019 Catalog Number : IE11002

Device Description : Multi-Band Ligation Kit

Device Class : 2

Duns Number: 046601986

Premarket Exempt : Yes

Product Code : FHN, MND

Prescription Use : Yes

Device Count : 1

SmartBand SafeGrip Multi-Band Ligation Kit - 00850261006033 Catalog Number : IE11004

Device Description : Multi-Band Ligation Kit

Device Class : 2

Duns Number: 046601986

Premarket Exempt : Yes

Product Code : FHN, MND

Prescription Use : Yes

Device Count : 1

SmartBand SafeGrip Multi-Band Ligation Pack - 00850261006040 Catalog Number : IE11003

Device Description : Multi-Band Ligation Pack

Device Class : 2

Duns Number: 046601986

Premarket Exempt : Yes

Product Code : MND, FHN

Prescription Use : Yes

Device Count : 1

SmartBand EMR Kit - 00850261006071 Catalog Number : SBEMRK

Device Description : SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in th SmartBand EMR Kit (10.75mm) 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

SmartBand EMR Pack - 00850261006088 Catalog Number : SBEMRP

Device Description : SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resect SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.

Device Class : 2

Duns Number: 046601986

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

SmartBand EMR Kit - 00850261006101 Catalog Number : SBEMRK12

Device Description : SmartBand EMR Kit (12mm) is indicated for endoscopic mucosal resection in the up SmartBand EMR Kit (12mm) 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

SmartBand EMR Pack - 00850261006118 Catalog Number : SBEMRP12

Device Description : SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.

Device Class : 2

Duns Number: 046601986

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

SmartSnare EMR Hexagonal Snare - 00850261006125 Catalog Number : SS2301

Device Description : SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.

Device Class : 2

Duns Number: 046601986

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

SmartBand EMR Pack - 00850261006200 Catalog Number : SBEMRP94

Device Description : SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resectio SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.

Device Class : 2

Duns Number: 046601986

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 1

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