Identity
- Trade Name
- Length Gauge, GammaMedplus FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Model / Reference
- GM11000330 FDA UDI
Identifiers
- Catalog Number
- GM11000330 FDA UDI
- Primary DI / UDI-DI
- 00816389021488 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
MR Unsafe FDA UDI
Category: Brachytherapy system remote afterloading source transfer tube
Length Gauge, GammaMedplus by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Brachytherapy system remote afterloading source transfer tube.
- MicroSelectron Digital — Nucletron B.V. · Class II
- MicroSelectron Digital — Nucletron B.V. · Class II
- MicroSelectron Digital — Nucletron B.V. · Class II
- Flexitron — Nucletron B.V. · Class II
- Flexitron — Nucletron B.V. · Class II
- Flexitron — Nucletron B.V. · Class II
- Flexitron — Nucletron B.V. · Class II
- MicroSelectron Digital — Nucletron B.V. · Class II
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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI 4bd0b0ca-aaf7-4a03-badd-6ab87925364d 34 fields · synced May 30, 2026