Identity
- Trade Name
- SmartBand EMR Pack FDA UDI
- Generic Name
- Oesophageal endoscopic ligator, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SBEMRP FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SBEMRP FDA UDI
- Primary DI / UDI-DI
- 00850261006088 FDA UDI
- 510(k) Number
- K212860 FDA UDI
- FDA Product Code
- FDI FDA UDI
- GMDN Term
- Oesophageal endoscopic ligator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- Not 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
SmartBand EMR Pack by Intelligent Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 ceb782b5-96d2-4c14-a71a-a26cff934b51 38 fields · synced Jun 8, 2026