Identity
- Trade Name
- Breast CT/MR Template FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Breast Template Holes 6-7 Spacing 16 FDA UDI
- Model / Reference
- 110469P01-00 FDA UDI
- Description
- Breast Template Holes 6-7 Spacing 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213040380 FDA UDI
- 510(k) Number
- K022635 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 16.0 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Breast CT/MR Template by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, remote-afterloading.
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Cleared under the same submission
K022635 also covers:
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — Nucletron B.V.
- Breast CT/MR Template — 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 e42a37f7-b924-4a87-98a3-7b75302fa781 36 fields · synced Jun 1, 2026