Identity
- Trade Name
- Vaginal CT/MR Multi Channel Applicator FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Segment Dorsal Ø25mm FDA UDI
- Model / Reference
- 110753-01 FDA UDI
- Description
- Segment Dorsal Ø25mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213052338 FDA UDI
- 510(k) Number
- K111973 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine 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
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 Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 25.0 Millimeter FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Vaginal CT/MR Multi Channel Applicator by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical/intrauterine brachytherapy system applicator, remote-afterloading.
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Ring Applicator Set 90 degree — Varian Medical Systems Deutschland GmbH · Class II
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Best Medical International — Best Medical International, Inc. · Class I
- Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 70 mm — Varian Medical Systems Deutschland GmbH · Class II
Cleared under the same submission
K111973 also covers:
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel Applicator — Nucletron B.V.
- Vaginal CT/MR Multi Channel 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 b68bef40-2312-4eb9-b7f9-077c5b2d45b3 36 fields · synced May 30, 2026