← Back to catalogue
Yellow Ø4.25mm Drill Sleeve (Length 138.5mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1127
by OrthoXel DAC
Identity
- Trade Name
- Yellow Ø4.25mm Drill Sleeve (Length 138.5mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Yellow Ø4.25mm Drill Sleeve (Length 138.5mm) EUDAMEDFDA UDI
- Model / Reference
- INS-1127 EUDAMEDFDA UDI
- Description
- Yellow Ø4.25mm Drill Sleeve (Length 138.5mm) FDA UDI
Identifiers
- Catalog Number
- INS-1127 FDA UDI
- Primary DI / UDI-DI
- 05391529584245 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529584245 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yellow Ø4.25mm Drill Sleeve (Length 138.5mm) by OrthoXel DAC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529584245 | 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 (2)
- EUDAMED 094cad29-1cb7-49c1-9839-a37455eb63bb 61 fields · synced Jun 18, 2026
- FDA UDI d6d8b16b-68d1-4db0-868c-190de1d3e628 37 fields · synced May 30, 2026