Identity
- Trade Name
- Bronchial catheter, 1.84 mm diameter, sterile FDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11002260 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816389022171 FDA UDI
- 510(k) Number
- K082653 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Bronchial catheter, 1.84 mm diameter, sterile by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K082653 also covers:
- Basket tube with three centering baskets, sterile, single use — Varian Medical Systems Deutschland GmbH
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH
- Clamping adapter for bronchial catheter ø 1.84 mm, GammaMedplus — Varian Medical Systems Deutschland GmbH
- Cleaning brush — Varian Medical Systems Deutschland GmbH
- Guide tube for centering catheter — Varian Medical Systems Deutschland GmbH
- Inner tube for centering catheter, sterile, single use — Varian Medical Systems Deutschland GmbH
- Length cutting gauge for bronchial catheters, 1.84 mm diameter — Varian Medical Systems Deutschland GmbH
- Lock screw for centering catheter, pack of 3 — Varian Medical Systems Deutschland GmbH
- Scaled pull rod, GammaMed only — Varian Medical Systems Deutschland GmbH
- Scaled pull rod, VariSource only — Varian Medical Systems Deutschland GmbH
- Bronchial catheter, ø 1.84 mm, sterile — Varian Medical Systems, Inc
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
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI 7bef17b4-c2ea-4f62-b67f-439d9028bb64 34 fields · synced Jun 1, 2026