Identity
- Trade Name
- Blue Eye FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Model / Reference
- TS-910 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809380057473 FDA UDI
- 510(k) Number
- K241591 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
No
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
No
FDA UDI
Category: Submucosal lift solution
Blue Eye by The Standard Co., 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
- Eleview 5mL — Cosmo Technologies, Ltd. · Class II
- Eleview — Cosmo Technologies, Ltd. · Class II
- ASCENDO submucosal lifting agent — US Endoscopy · Class II
Cleared under the same submission
K241591 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Standard Co., Ltd.
Sources (1)
- FDA UDI c19f240a-f532-4c3c-84cb-27ad2ff70b2b 33 fields · synced Jun 1, 2026