Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- Surgical Instrument EUDAMEDHUDSON EXTENSION PIECE FIG. 9 FDA UDI
- Model / Reference
- KO.1155.09 EUDAMEDFDA UDI
- Description
- HUDSON EXTENSION PIECE FIG. 9 FDA UDI
Identifiers
- Catalog Number
- KO.1155.09 FDA UDI
- Primary DI / UDI-DI
- 04049047061793 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047LCR03ANA27DROSB EUDAMED
- Direct Marketing DI
- 04049047061793 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Manual surgical rotary handpiece, reusable
Gimmi by Gimmi GmbH — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 4b4ceb32-4aea-4cff-8150-a0d8992536a2 35 fields · synced Jul 16, 2026
- EUDAMED f0e47d9c-aa36-4c86-95d9-d7e8929fe280 61 fields · synced Jul 16, 2026