Identity
- Trade Name
- Eleview FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not for resale. FDA UDI
- Model / Reference
- 9000008 FDA UDI
- Description
- 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not for resale. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391530190053 FDA UDI
- FDA Product Code
- PLL FDA UDI
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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: Submucosal lift solution
Eleview by Cosmo Technologies, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal lift solution.
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- EndoClot SIS — EndoClot Plus, Inc. · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ASCENDO submucosal lifting agent — US Endoscopy · Class II
- Ascendo — US Endoscopy · Class II
- Blue Eye — THE STANDARD CO., LTD. · Class II
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
- Cosmo Technologies, Ltd.
Sources (1)
- FDA UDI e7de8094-d3a0-46c7-a5d1-c47c5cb24261 34 fields · synced Jun 7, 2026