Identity
- Trade Name
- EverLift Submucosal Lifting Agent EUDAMEDEverLift FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- EverLift Submucosal Lifting Agent (5mL) EUDAMEDSubmucosal Lifting Agent - 5mL Single Unit FDA UDI
- Model / Reference
- GIS-55 EUDAMEDFDA UDI
- Description
- Submucosal Lifting Agent - 5mL Single Unit FDA UDI
Identifiers
- Catalog Number
- GIS-55 FDA UDI
- Primary DI / UDI-DI
- 00893029002229 EUDAMEDFDA UDI
- Basic UDI-DI
- 0893029002EverLiftAW EUDAMED
- 510(k) Number
- K191923 FDA UDI
- FDA Product Code
- PLL FDA UDI
- EMDN Code
- G030399 POLYPECTOMY DEVICES - OTHER EUDAMED
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
EverLift Submucosal Lifting Agent by GI Supply, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0893029002EverLiftAW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GI Supply, Inc.
- EUDAMED SRN
- US-MF-000002609
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3e23c104-ded3-422d-9765-28fae7d3d485 61 fields · synced Jul 15, 2026
- FDA UDI 6c1966a9-38f0-437f-9088-4b97bbd7d9d0 35 fields · synced May 30, 2026