Identity
- Trade Name
- Interstitial needles FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, manual FDA UDI
- Device Name
- Trocar Needle 1.9mm x 100mm FDA UDI
- Model / Reference
- 083052P02-00 FDA UDI
- Description
- Trocar Needle 1.9mm x 100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213052178 FDA UDI
- 510(k) Number
- K091154 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Vaginal brachytherapy system applicator, manual 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
- Outer Diameter — 1.9 Millimeter FDA UDILength — 100.0 Millimeter FDA UDI
Category: Vaginal brachytherapy system applicator, manual
Interstitial needles by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vaginal brachytherapy system applicator, manual.
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- Gynecological Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
- Gynecological Template — LIBERTY MEDICAL INC · Class I
- Gynecological Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
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.
- Interstitial needles — Nucletron B.V.
- ProGuide Needles — 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 969cbb71-ea06-432c-bb81-5480b8527a82 36 fields · synced Jun 8, 2026