Identity
- Trade Name
- Esophageal Applicator FDA UDI
- Generic Name
- Oesophagus brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Esophageal Applicator Set, Ø 8 mm, 100 cm FDA UDI
- Model / Reference
- 085005-02 FDA UDI
- Description
- Esophageal Applicator Set, Ø 8 mm, 100 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213009035 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Oesophagus 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
Yes
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
High-level Disinfectant FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 100.0 Centimeter FDA UDIOuter Diameter — 8.0 Millimeter FDA UDI
Category: Oesophagus brachytherapy system applicator, remote-afterloading
Esophageal Applicator by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oesophagus brachytherapy system applicator, remote-afterloading.
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- Esophagus bougie diameter 10 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH · Class II
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
- Nucletron B.V.
Sources (1)
- FDA UDI 5d87d708-f355-45b6-9ae3-aa68d1bb18a6 36 fields · synced May 30, 2026