Identity
- Trade Name
- Cleaning Caps, black (pack of 20) FDA UDI
- Generic Name
- Tongue brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11003220 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816389027135 FDA UDI
- 510(k) Number
- K141336 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Tongue brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cleaning Caps, black (pack of 20) by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K141336 also covers:
- Accessory Kit - "Light" Version for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Accessory Kit for Flexible Interstitial Implant Set, GammaMed — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Intracavitary/GYN Applicators, GammaMed — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Intraluminal Applicators, GammaMedplus — Varian Medical Systems Deutschland GmbH
- Basic accessory kit for intracavitary / GYN applicators, VariSource — Varian Medical Systems Deutschland GmbH
- Cleaning caps gray (pack of 20) — Varian Medical Systems Deutschland GmbH
- Cleaning caps green (pack of 20) — Varian Medical Systems Deutschland GmbH
- Complete Accessory Kit for Interstitial Applicators — Varian Medical Systems Deutschland GmbH
- Complete Kit for Heyman Packing Applicator & Catheter Flap Sets, GammaMed — Varian Medical Systems Deutschland GmbH
- Connecting tube 113 mm interstitial tube for PDR quick connector (1 per channel) — Varian Medical Systems Deutschland GmbH
- Connecting tube 113 mm needle for PDR quick connector (1 per channel) — Varian Medical Systems Deutschland GmbH
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
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI f8e7119c-d8c4-4adc-af9f-823aaab5d487 34 fields · synced May 30, 2026