Identity
- Trade Name
- Bite protector, 10 mm diameter (with strap) FDA UDI
- Generic Name
- Oesophagus brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11007460 FDA UDI
Identifiers
- Catalog Number
- GM11007460 FDA UDI
- Primary DI / UDI-DI
- 00816389024199 FDA UDI
- 510(k) Number
- K130251 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDI
Category: Oesophagus brachytherapy system applicator, remote-afterloading
Bite protector, 10 mm diameter (with strap) by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophagus brachytherapy system applicator, remote-afterloading.
- Esophageal Applicator — Nucletron B.V. · Class II
- Esophageal Applicator — Nucletron B.V. · Class II
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V. · Class II
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V. · Class II
- Esophageal Applicator — Nucletron B.V. · Class II
- Esophageal Applicator — Nucletron B.V. · Class II
- Esophageal Applicator — Nucletron B.V. · Class II
- Bonvoisin-Gerard Esophageal Applicator (Flexitron) — Nucletron B.V. · Class II
Cleared under the same submission
K130251 also covers:
- Bite protector, 12 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH
- Bite protector, 14 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH
- Bite protector, 8 mm diameter (with strap) — Varian Medical Systems Deutschland GmbH
- Clamping screw with fixation nut for bougies — Varian Medical Systems Deutschland GmbH
- Cleaning Brush Esophagus Bougies — Varian Medical Systems Deutschland GmbH
- Cleaning caps, blue (pack of 20) — Varian Medical Systems Deutschland GmbH
- Esophagus Bougie Set — Varian Medical Systems Deutschland GmbH
- Esophagus bougie diameter 10 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH
- Esophagus bougie diameter 12 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH
- Esophagus bougie diameter 14 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH
- Esophagus bougie diameter 8 mm, with bite protector and fixation — Varian Medical Systems Deutschland GmbH
- Tube catheter 3.2 mm diameter, GammaMedplus — Varian Medical Systems Deutschland GmbH
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
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI b380be53-58e7-4f7c-8fb6-b397cd37fd54 35 fields · synced Jun 8, 2026