Identity
- Trade Name
- Vaginal CT/MR Applicator FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Cylinder Fixation FDA UDI
- Model / Reference
- 101006P01-03 FDA UDI
- Description
- Cylinder Fixation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213030114 FDA UDI
- 510(k) Number
- K983341 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
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Vaginal CT/MR Applicator 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
K983341 also covers:
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher CT/MR Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
- Fletcher Williamson Applicator — Nucletron B.V.
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 e484fe2c-2ac7-4997-a92c-fb18b5cf9360 35 fields · synced May 30, 2026