Identity
- Trade Name
- Ambu® Pedicle Screw Probe EUDAMEDAmbu Pedicle Screw ProbeSingle Patient Probes FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Stimulation Probes and Surgical Instruments EUDAMEDAmbu Disposable IOM Stimulation Probes 100 mm long Pedicle Screw needle with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale FDA UDI
- Model / Reference
- 73600-190/10 EUDAMEDFDA UDI
- Description
- Ambu Disposable IOM Stimulation Probes 100 mm long Pedicle Screw needle with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale FDA UDI
Identifiers
- Catalog Number
- 73600-190/10 FDA UDI
- Primary DI / UDI-DI
- 05707480108497 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05707480108497 EUDAMED
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- Z12101185 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDILength — 190 Centimeter FDA UDI
Ambu® Pedicle Screw Probe by Technomed Europe — Class IIa — 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-05707480108497 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED a8f77e92-864d-4085-9077-ebe6318d6c99 61 fields · synced Jul 16, 2026
- FDA UDI e8fc302a-fe9f-4842-9acb-70dc9c9e32d8 37 fields · synced May 22, 2026