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EverLift Submucosal Lifting Agent
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GIS-59Model GIS-55
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 - 10mL Single Unit FDA UDI
- Model / Reference
- GIS-55 EUDAMEDGIS-59 EUDAMEDFDA UDI
- Description
- Submucosal Lifting Agent - 10mL Single Unit FDA UDI
Identifiers
- Catalog Number
- GIS-59 FDA UDI
- Primary DI / UDI-DI
- 00893029002243 EUDAMEDFDA UDI
- Basic UDI-DI
- 0893029002EverLiftAW EUDAMED
- 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202376 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191923 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0893029002EverLiftAW | Class IIa | Active |
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Manufacturer
- Manufacturer
- GI Supply, Inc.
- EUDAMED SRN
- US-MF-000002609
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 207dd1ff-e7a4-460a-8ec3-953d992fd288 61 fields · synced Jul 22, 2026
- FDA UDI 013abb7b-ff86-4991-b10a-9084a815e142 34 fields · synced May 30, 2026
- FDA 510(k) K202376 1 fields · synced May 18, 2026