Identity
- Trade Name
- Keyless Chuck EUDAMEDApex FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- Keyless Chuck EUDAMEDFDA UDI
- Model / Reference
- INS-1022 EUDAMEDFDA UDI
- Description
- Keyless Chuck FDA UDI
Identifiers
- Catalog Number
- INS-1022 FDA UDI
- Primary DI / UDI-DI
- 05391529582357 EUDAMEDFDA UDI
- Basic UDI-DI
- 53915295823576R EUDAMEDB-05391529582357 EUDAMED
- Direct Marketing DI
- 05391529582357 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER 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
- Ireland 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Keyless Chuck by OrthoXel DAC — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 53915295823576R | Class I | Active |
| EUDAMED | European Union | CE/MDR | 53915295823576R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED c8fc5814-f6a9-481f-b75a-dc6e845f7e0a 61 fields · synced Jul 24, 2026
- EUDAMED 38f8ac72-08b5-4f18-a625-67d678828eaf 61 fields · synced May 18, 2026
- FDA UDI 9298f600-e78f-4e9c-b018-3a4955692f57 36 fields · synced May 30, 2026