Identity
- Trade Name
- Utrecht Interstitial Fletcher CT/MR Applicator FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Guiding Tube for Ovoids FDA UDI
- Model / Reference
- 110235-01 FDA UDI
- Description
- Guiding Tube for Ovoids FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213053663 FDA UDI
- 510(k) Number
- K091154 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Utrecht Interstitial Fletcher CT/MR 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
K091154 also covers:
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial Ring CT/MR Applicator — Nucletron B.V.
- Interstitial needles — Nucletron B.V.
- Interstitial needles — Nucletron B.V.
- Interstitial needles — Nucletron B.V.
- Interstitial needles — Nucletron B.V.
- Interstitial needles — Nucletron B.V.
- ProGuide Needles — 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 0b0bf6ae-0d72-4928-9c33-371b830fb6a6 35 fields · synced May 30, 2026