Identity
- Trade Name
- Scaled pull rod, GammaMed only FDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11008040 FDA UDI
Identifiers
- Catalog Number
- GM11008040 FDA UDI
- Primary DI / UDI-DI
- 00816389024465 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
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bronchial brachytherapy system applicator, remote-afterloading
Scaled pull rod, GammaMed only by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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, 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 |
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Manufacturer
- Manufacturer
- Varian Medical Systems Deutschland GmbH
Sources (1)
- FDA UDI 44949a66-64e5-4830-90e6-6a2382f65f5b 34 fields · synced May 31, 2026