Identity
- Trade Name
- AccuBoost® FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- Catheter Assembly – 4 cm Round – 3 Pack FDA UDI
- Model / Reference
- 450110-00 FDA UDI
- Description
- Catheter Assembly – 4 cm Round – 3 Pack FDA UDI
Identifiers
- Catalog Number
- ART -CAT-4 FDA UDI
- Primary DI / UDI-DI
- 00850306007230 FDA UDI
- 510(k) Number
- K062135 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 4 Centimeter FDA UDI
Category: General-purpose brachytherapy system applicator, manual
AccuBoost® by Advanced Radiation Therapy, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, manual.
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Cleared under the same submission
K062135 also covers:
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
- AccuBoost® — ADVANCED RADIATION THERAPY, LLC
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 |
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Manufacturer
- Manufacturer
- Advanced Radiation Therapy, Llc
Sources (1)
- FDA UDI 7c50117a-ffbf-4aee-b1e7-e0bdb6054627 37 fields · synced Jun 8, 2026