SmartBand Ligation Kit

FDA UDI

Class II (US FDA UDI)

by Intelligent Endoscopy

Identity

Trade Name: SmartBand Ligation Kit FDA UDI
Generic Name: Oesophageal endoscopic ligator, single-use FDA UDI
Device Name: Multi-Band Ligation Kit FDA UDI
Model / Reference: SLK-6 FDA UDI
Description: Multi-Band Ligation Kit FDA UDI

Identifiers

Catalog Number: IE11002 FDA UDI
Primary DI / UDI-DI: 00850261006019 FDA UDI
FDA Product Code: FHN FDA UDI
MND FDA UDI
GMDN Term: Oesophageal endoscopic ligator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 13.938 Inch FDA UDI
Weight — 0.25 Pound FDA UDI
Depth — 1.938 Inch FDA UDI
Width — 10.875 Inch FDA UDI

Category: Oesophageal endoscopic ligator, single-use

SmartBand Ligation Kit by Intelligent Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Intelligent Endoscopy

Sources (1)

FDA UDI 2087a78a-e0f8-4f55-aebf-906c10c54651 36 fields · synced May 30, 2026