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X-ray marker BV, up to 320 mm applicators, uncoded
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- X-ray marker BV, up to 320 mm applicators, uncoded FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Model / Reference
- GM11009600 FDA UDI
Identifiers
- Catalog Number
- GM11009600 FDA UDI
- Primary DI / UDI-DI
- 00816389024861 FDA UDI
- 510(k) Number
- K983436 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
Moist Heat or Steam Sterilization FDA UDI
Category: Brachytherapy system remote afterloading source transfer tube
X-ray marker BV, up to 320 mm applicators, uncoded by Varian Medical Systems Deutschland GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Brachytherapy system remote afterloading source transfer tube.
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Cleared under the same submission
K983436 also covers:
- 4 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 5 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 5 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 6 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 7 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 7 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- 8 cm intrauterine probe angled 40 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH
- Accessory Kit for Flexible Interstitial Implant Set, GammaMed — Varian Medical Systems Deutschland GmbH
- Base plate for 1.65mm steel needles — 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
- Catheter Flap Set — Varian Medical Systems Deutschland GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 940fbee8-00fb-4468-8cf2-08888b576fcf 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026