Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Trocar Systems & Accessories EUDAMEDALPHAPORT REDUCER, REMOVABLE FROM Ø 5.5 MM TO 2.7 / 3.0 MM FDA UDI
- Model / Reference
- T.8026.09 EUDAMEDFDA UDI
- Description
- ALPHAPORT REDUCER, REMOVABLE FROM Ø 5.5 MM TO 2.7 / 3.0 MM FDA UDI
Identifiers
- Catalog Number
- T.8026.09 FDA UDI
- Primary DI / UDI-DI
- 04049047638407 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LFP09BJA27DREVZ EUDAMED
- Direct Marketing DI
- 04049047638407 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L031280 SURGICAL TROCAR, REUSABLE - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope sheath, reusable
Gimmi by Gimmi GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 8e455307-54a6-4afb-8d4c-a0bb46a20208 35 fields · synced Jun 18, 2026
- EUDAMED e973b1aa-de76-4ee8-ac3b-4ea7f42c7e58 61 fields · synced Jun 18, 2026