Identity
- Trade Name
- Esophageal Applicator FDA UDI
- Generic Name
- Oesophagus brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Esophageal Applicator Set, 6 mm, 150 cm FDA UDI
- Model / Reference
- 085055-03 FDA UDI
- Description
- Esophageal Applicator Set, 6 mm, 150 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213009301 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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 150.0 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
Similar devices
Also classified as Oesophagus brachytherapy system applicator, remote-afterloading.
- Esophagus bougie diameter 8 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH · Class II
- cleaning set for esophagus bougies — Varian Medical Systems Deutschland GmbH · Class II
- Bite protector, 12 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH · Class II
- Bite protector, 10 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH · Class II
- Bite protector, 8 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH · Class II
- Tube catheter 3.2 mm diameter, VS — Varian Medical Systems Deutschland GmbH · Class II
- Esophagus bougie diameter 12 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI fefd3890-2d3c-41b1-b553-ecfdb8c1ed7a 36 fields · synced May 31, 2026