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Source guide tube with locking mechanism for 180 mm needles without connector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Source guide tube with locking mechanism for 180 mm needles without connector FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Model / Reference
- GM11006060 FDA UDI
Identifiers
- Catalog Number
- GM11006060 FDA UDI
- Primary DI / UDI-DI
- 00816389023642 FDA UDI
- 510(k) Number
- K141336 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Brachytherapy system remote afterloading source transfer tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 180 Millimeter FDA UDI
Category: Brachytherapy system remote afterloading source transfer tube
Source guide tube with locking mechanism for 180 mm needles without connector by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA…
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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 Deutschland GmbH
Sources (1)
- FDA UDI 11e4bcce-8468-4b96-9f15-d7b893d39d5d 35 fields · synced May 31, 2026