Identity
- Trade Name
- Obturator and Caps FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- 530312 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005821204 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Obturator and Caps by Concure Oncology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
K070574 also covers:
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- 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.
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- 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
- Concure Oncology, Inc.
Sources (1)
- FDA UDI f47c0bec-865e-4748-ac7f-cc3aa5d4e374 33 fields · synced Jun 8, 2026