Identity
- Trade Name
- Extend Frame system FDA UDI
- Generic Name
- Teletherapy radionuclide system, conventional FDA UDI
- Device Name
- SALIVA STOP HOLDER (3PCS) FDA UDI
- Model / Reference
- 1013559 FDA UDI
- Description
- SALIVA STOP HOLDER (3PCS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340048307970 FDA UDI
- FDA Product Code
- IWB FDA UDI
- GMDN Term
- Teletherapy radionuclide system, conventional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5750 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Extend Frame system by Elekta Instrument AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA UDI f3eb8e1b-3033-4c95-9f65-50dddbb6c51b 35 fields · synced May 30, 2026