Identity
- Trade Name
- Flexitron FDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- Flexitron Stainless Steel Transfer Tube for channel 3 (2) FDA UDI
- Model / Reference
- 111682-01 FDA UDI
- Description
- Flexitron Stainless Steel Transfer Tube for channel 3 (2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213026483 FDA UDI
- 510(k) Number
- K070574 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Brachytherapy system remote afterloading source transfer tube 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
MR Unsafe FDA UDI
Category: Brachytherapy system remote afterloading source transfer tube
Flexitron by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Brachytherapy system remote afterloading source transfer tube.
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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.
- Cervix Rotterdam Applicator — 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 30fa171c-4f07-4620-bfeb-fc934b425fb1 36 fields · synced Jun 8, 2026