Identity
- Trade Name
- Mallet Guide EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Device Name
- Mallet Guide EUDAMEDFDA UDI
- Model / Reference
- INS-1064 EUDAMEDFDA UDI
- Description
- Mallet Guide FDA UDI
Identifiers
- Catalog Number
- INS-1064 FDA UDI
- Primary DI / UDI-DI
- 05391529582753 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582753 EUDAMED539152958275375 EUDAMED
- Direct Marketing DI
- 05391529582753 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantation hammering attachment 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
Mallet Guide by OrthoXel DAC — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05391529582753 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529582753 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED 8ea32b63-9ce8-47e5-b4d8-649038148cdd 61 fields · synced Jul 15, 2026
- EUDAMED 7ed6cc65-528c-4bf7-827d-87bfc98d7a0a 61 fields · synced May 17, 2026
- FDA UDI 20d72e63-f553-4928-a873-97393a15d8e6 35 fields · synced May 30, 2026