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SmartBand SafeGrip Multi-Band Ligation Kit

FDA UDI

Class II (US FDA UDI)

by Intelligent Endoscopy

Identity

Trade Name
SmartBand SafeGrip Multi-Band 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-LF FDA UDI
Description
Multi-Band Ligation Kit FDA UDI

Identifiers

Catalog Number
IE11004 FDA UDI
Primary DI / UDI-DI
00850261006033 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

No

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

Category: Oesophageal endoscopic ligator, single-use

SmartBand SafeGrip Multi-Band Ligation Kit 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 eb817852-1ba3-4745-8368-8822465be046 36 fields · synced May 29, 2026