Identity
- Trade Name
- Cervix Rotterdam Applicator FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Vaginal Cylinder Body 15°, 37mm FDA UDI
- Model / Reference
- 137484-01 FDA UDI
- Description
- Vaginal Cylinder Body 15°, 37mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213037885 FDA UDI
- 510(k) Number
- K070574 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
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 Conditional FDA UDI
Dimensions & Sizes
- Size
- Angle — 15.0 degree FDA UDIOuter Diameter — 37.0 Millimeter FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Cervix Rotterdam 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
K070574 also covers:
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Cervix Rotterdam Applicator — Nucletron B.V.
- Flexitron — Nucletron B.V.
- Flexitron — 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 24a81b64-4ff6-4ac7-b22a-80d95cdf6392 37 fields · synced Jun 1, 2026