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Bonvoisin-Gerard Esophageal Applicator (Flexitron)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) FDA UDI
- Generic Name
- Oesophagus brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Bonvoisin Gerard Esophageal Applicator, 24F (Ø 8 mm) FDA UDI
- Model / Reference
- 137263P01-03 FDA UDI
- Description
- Bonvoisin Gerard Esophageal Applicator, 24F (Ø 8 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213039612 FDA UDI
- 510(k) Number
- K082530 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
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8.0 Millimeter FDA UDI
Category: Oesophagus brachytherapy system applicator, remote-afterloading
Bonvoisin-Gerard Esophageal Applicator (Flexitron) 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
Cleared under the same submission
K082530 also covers:
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V.
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — 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 |
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Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI cf44ccf7-2d70-47f7-affa-b2716b792b1b 37 fields · synced Jun 8, 2026