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Cervical sleeve IU ø6.4mm, 60mm, with marker
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011380
Identity
- Trade Name
- Cervical sleeve IU ø6.4mm, 60mm, with marker EUDAMEDCervical Sleeve IU 6.4mm diameter, 60mm diameter, with marker FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Cervical Sleeves EUDAMED
- Model / Reference
- GM11011380 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011380 FDA UDI
- Primary DI / UDI-DI
- 00816389026124 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201157QC EUDAMED
- 510(k) Number
- K150839 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine 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 UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Cervical sleeve IU ø6.4mm, 60mm, with marker by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500201157QC | 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 (2)
- EUDAMED 060980b3-7f48-4751-9cc4-0de4f63a2fd0 61 fields · synced Jun 17, 2026
- FDA UDI c5d21a57-a227-4910-a393-89f7e2613949 35 fields · synced May 30, 2026