← Back to catalogue

SmartBand EMR Pack

FDA UDI

Class II (US FDA UDI)

by Intelligent Endoscopy

Identity

Trade Name
SmartBand EMR Pack FDA UDI
Generic Name
Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI
Device Name
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. FDA UDI
Model / Reference
SBEMRP94 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
SBEMRP94 FDA UDI
Primary DI / UDI-DI
00850261006200 FDA UDI
510(k) Number
K212860 FDA UDI
FDA Product Code
FDI FDA UDI
GMDN Term
Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic electrosurgical mucosal biopsy/resection set

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

Similar devices

Also classified as Endoscopic electrosurgical mucosal biopsy/resection set.

Cleared under the same submission

K212860 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Intelligent Endoscopy

Sources (1)

  • FDA UDI 8f30d20b-8640-418b-bb55-751b7542a889 37 fields · synced Jun 8, 2026