Identity
- Trade Name
- Interstitial needles FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Obturator for 1.9mm Needle x 80mm FDA UDI
- Model / Reference
- 083250P02-00 FDA UDI
- Description
- Obturator for 1.9mm Needle x 80mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213052154 FDA UDI
- 510(k) Number
- K091154 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 80.0 Millimeter FDA UDIOuter Diameter — 1.9 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Interstitial needles by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose brachytherapy system applicator, remote-afterloading.
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- Best Medical International — Best Medical International, Inc. · Class I
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- 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
- Best Medical International — Best Medical International, Inc. · Class I
- Surface cone inset, 30 diameter x 20 mm, oval — 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.
- ProGuide 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 1f85dda6-bc4c-4fe5-be62-14ba84bf4c30 36 fields · synced May 30, 2026