Identity
- Trade Name
- Surface cone inset, 45 mm diameter, round FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11003630 FDA UDI
Identifiers
- Catalog Number
- GM11003630 FDA UDI
- Primary DI / UDI-DI
- 00816389022782 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- General-purpose 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 45 Millimeter FDA UDI
Category: General-purpose brachytherapy system applicator, remote-afterloading
Surface cone inset, 45 mm diameter, round 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
K123815 also covers:
- Leipzig-style cone 30-45 mm diameter, with holder and guide — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 30 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 35 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 40 mm diameter, round — Varian Medical Systems Deutschland GmbH
K162018 also covers:
- Shielding for cone, 10-25 mm diameter, with fixation — Varian Medical Systems Deutschland GmbH
- Shielding for cone, 30-45 mm diameter, with fixation — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 15 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 25 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 30 diameter x 20 mm, oval — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 30 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 35 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 40 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 45 diameter x 25 mm, oval — Varian Medical Systems Deutschland GmbH
- Surface cone inset, ø20 mm, round — 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 12d7d95d-00d1-456e-8458-5a46d5c8df72 35 fields · synced May 30, 2026