Identity
- Trade Name
- ProGuide Needles FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- ProGuide Round Needle 6Fx294mm FDA UDI
- Model / Reference
- 110233-00 FDA UDI
- Description
- ProGuide Round Needle 6Fx294mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213025202 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
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
Dimensions & Sizes
- Size
- Catheter Gauge — 6.0 French FDA UDILength — 294.0 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
ProGuide Needles by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K060349 also covers:
- Obturator and Caps — CONCURE ONCOLOGY, INC.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
- ProGuide Needles — Nucletron B.V.
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.
- Ring CT/MR 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 1623d3cb-db77-4594-aa7f-daee60cace2d 36 fields · synced May 30, 2026