Identity
- Trade Name
- MicroSelectron Digital FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Calibration Tube FDA UDI
- Model / Reference
- 084119P01-00 FDA UDI
- Description
- Calibration Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213036796 FDA UDI
- 510(k) Number
- K061354 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Vaginal brachytherapy system applicator, remote-afterloading 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Vaginal brachytherapy system applicator, remote-afterloading
MicroSelectron Digital by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
- Smit cervical sleeve 40 mm, with clamping for guiding tube — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 70 mm — Varian Medical Systems Deutschland GmbH · Class II
- Source guide tube with locking mechanism, third party applicator — Varian Medical Systems, Inc · Class II
- Front segment open 35 mm diameter, straight, length 60 mm — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe 3mm diameter x 320 mm, straight — Varian Medical Systems Deutschland GmbH · Class II
- Surface cone inset, ø20 mm, round — Varian Medical Systems Deutschland GmbH · Class II
- 5 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm — Varian Medical Systems Deutschland GmbH · Class II
Cleared under the same submission
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
- Nucletron B.V.
Sources (1)
- FDA UDI 41c108d3-a26c-4ddc-ae6a-71bdc6cb6c21 35 fields · synced May 30, 2026