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Smit cervical sleeves ø 3 mm, 40mm length, with marker
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11000960
Identity
- Trade Name
- Smit cervical sleeves ø 3 mm, 40mm length, with marker EUDAMEDFDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Cervical Sleeves EUDAMED
- Model / Reference
- GM11000960 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11000960 FDA UDI
- Primary DI / UDI-DI
- 00810563022438 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201157QC EUDAMED
- 510(k) Number
- K241853 FDA UDI
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Smit cervical sleeves ø 3 mm, 40mm length, with marker by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172675 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201157QC | Class IIa | Active |
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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 (3)
- EUDAMED c6d66b85-98e7-4815-8ab8-c4e4cbf5390e 61 fields · synced Jul 13, 2026
- FDA UDI 3d5f859f-35ec-4d4a-97c0-e86baad12d91 34 fields · synced May 30, 2026
- FDA 510(k) K172675 1 fields · synced May 18, 2026