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Locking Screw Length Gauge (Hook)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1128
by OrthoXel DAC
Identity
- Trade Name
- Locking Screw Length Gauge (Hook) EUDAMEDApex FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Locking Screw Length Gauge (Hook) EUDAMEDFDA UDI
- Model / Reference
- INS-1128 EUDAMEDFDA UDI
- Description
- Locking Screw Length Gauge (Hook) FDA UDI
Identifiers
- Catalog Number
- INS-1128 FDA UDI
- Primary DI / UDI-DI
- 05391529583071 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529583071 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
Yes
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
Locking Screw Length Gauge (Hook) 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-05391529583071 | 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 (2)
- EUDAMED 6860f787-d664-4d76-aa18-3668f4e1c870 61 fields · synced Jun 18, 2026
- FDA UDI 50a77e34-3cbc-498b-8db3-591d51945e8c 36 fields · synced May 30, 2026