Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Product for cleaning and storage EUDAMEDSCREEN BASKET LID 1/1 STAINLESS STEEL PERFORATED 543 X 253 MM FDA UDI
- Model / Reference
- R.0100.00 II EUDAMEDFDA UDI
- Description
- SCREEN BASKET LID 1/1 STAINLESS STEEL PERFORATED 543 X 253 MM FDA UDI
Identifiers
- Catalog Number
- R.0100.00 II FDA UDI
- Primary DI / UDI-DI
- 04049047667827 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047SAA08ABA27DRBCW EUDAMED
- Direct Marketing DI
- 04049047667827 EUDAMED
- 510(k) Number
- K123234 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Gimmi by Gimmi GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 f02d9ac9-262f-428e-b99f-0003d453eaa5 36 fields · synced Jul 14, 2026
- EUDAMED 4f985056-59ee-4cd2-ac20-19967e354205 61 fields · synced Jul 14, 2026