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Screwdriver Activator for Matrix CM Dalbo®-Plus
FDA UDIEUDAMEDClass I (US FDA UDI)
by ALTATEC GmbH
Identity
- Trade Name
- Screwdriver Activator for Matrix CM Dalbo®-Plus FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screwdriver Activator for Matrix CM Dalbo®-Plus FDA UDI
- Model / Reference
- J5315.0005 FDA UDI
- Description
- Screwdriver Activator for Matrix CM Dalbo®-Plus FDA UDI
Identifiers
- Catalog Number
- J5315.0005 FDA UDI
- Primary DI / UDI-DI
- E219J531500051 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Screwdriver Activator for Matrix CM Dalbo®-Plus by ALTATEC GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (2)
- FDA UDI 825fe5c6-4245-4491-a2af-e667d8a655ae 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026