← Back to catalogue
Cleaning Cap, dark blue (pack of 25)
EUDAMEDFDA UDIClass I (EU MDR)
Ref GM11010770
Identity
- Trade Name
- Cleaning Cap, dark blue (pack of 25) EUDAMEDFDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Cleaning Cap, dark blue (Pack of 25) EUDAMED
- Model / Reference
- GM11010770 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11010770 FDA UDI
- Primary DI / UDI-DI
- 10816389027234 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201122PR EUDAMED
- Unit of Use DI
- 00816389027237 EUDAMED
- 510(k) Number
- K152018 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class I 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
Yes
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 Safe FDA UDI
Cleaning Cap, dark blue (pack of 25) by Varian Medical Systems, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 089947500201122PR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED 575c62f5-e47a-4e1d-b9c5-4c4c35d5bb0a 61 fields · synced Jun 18, 2026
- FDA UDI 32821018-a51d-45aa-b42e-5cccb86600fe 34 fields · synced May 30, 2026
- EUDAMED 8ba10941-7a7b-456e-bb58-b1f7fb48ba2b 61 fields · synced Jun 18, 2026