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Ovoid \ cervical stop set screw (pack of 8)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AL07335000Ref GM11000670
Identity
- Trade Name
- Ovoid \ cervical stop set screw (pack of 8) EUDAMEDFDA UDICervical Stop EUDAMEDCervical stopper FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Headless screw titanium EUDAMEDCervical Stop EUDAMED
- Model / Reference
- AL07335000 EUDAMEDFDA UDIGM11000670 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11000670 FDA UDIAL07335000 FDA UDI
- Primary DI / UDI-DI
- 10810563022930 EUDAMEDFDA UDI00816389021624 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201153Q4 EUDAMEDB-00816389021624 EUDAMED
- Unit of Use DI
- 00810563022933 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Ovoid \ cervical stop set screw (pack of 8) by Varian Medical Systems, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 089947500201153Q4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201153Q4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (4)
- EUDAMED 9ad6d404-1bca-4a47-ba5a-7792b0248f11 61 fields · synced Oct 6, 2026
- FDA UDI b0ee7438-75d4-4b34-981e-11edd478b793 34 fields · synced May 29, 2026
- FDA UDI 76aec048-bf71-4224-9608-a69944d94991 34 fields · synced May 30, 2026
- EUDAMED 2a3bfc1e-08c9-4da8-a644-19dc80d24777 61 fields · synced Jul 29, 2026