Identity
- Trade Name
- Awl EUDAMED
- Device Name
- Lumbar Instruments EUDAMED
- Model / Reference
- I009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251631400233 EUDAMED
- Basic UDI-DI
- 42516314TD012I49 EUDAMED
- Direct Marketing DI
- 04251631400233 EUDAMED
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Surgical implant template, reusable
Awl by NGMedical GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42516314TD012I49 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NGMedical GmbH
- EUDAMED SRN
- DE-MF-000000204
Sources (1)
- EUDAMED a6789969-25d4-4ee2-8d22-8e9ccbd460f1 61 fields · synced Oct 6, 2026