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SmartBand Ligation Pack

FDA UDI

Class II (US FDA UDI)

by Intelligent Endoscopy

Identity

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

Identifiers

Catalog Number
IE11001 FDA UDI
Primary DI / UDI-DI
00850261006002 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Depth — 0.625 Inch FDA UDI
Width — 5.063 Inch FDA UDI
Weight — 0.05 Pound FDA UDI
Height — 8 Inch FDA UDI

Category: Oesophageal endoscopic ligator, single-use

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

Similar devices

Also classified as Oesophageal endoscopic ligator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intelligent Endoscopy

Sources (1)

  • FDA UDI 2cdc020f-4e69-42fa-8ed1-c28531e969d0 36 fields · synced Jun 8, 2026