Identity
- Trade Name
- Cylinder segment, 20 mm diameter, 30 mm length FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11005070 FDA UDI
Identifiers
- Catalog Number
- GM11005070 FDA UDI
- Primary DI / UDI-DI
- 00816389023444 FDA UDI
- 510(k) Number
- K160516 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Vaginal 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 20 Millimeter FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Cylinder segment, 20 mm diameter, 30 mm length by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
- Source guide tube with locking mechanism, third party applicator — Varian Medical Systems, Inc · Class II
- Vaginal Applicator — Nucletron B.V. · Class II
- Miami Vaginal Applicator — Nucletron B.V. · Class II
- Vaginal CT/MR Applicator — Nucletron B.V. · Class II
- Vaginal CT/MR Applicator — Nucletron B.V. · Class II
- Kobold® Vaginal Cylinder Applicator Set (E) — KOBOLD, LLC · Class II
- Wall holder for source and transfer guide tubes — Varian Medical Systems, Inc · Class II
- Vaginal Applicator — Nucletron B.V. · Class II
Cleared under the same submission
K160516 also covers:
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degree, 50 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 30 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 40 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 70 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 80 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degree, 30 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degree, 50 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 40 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 60 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 70 mm — Varian Medical Systems Deutschland GmbH
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 80 mm — 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 32dca5e9-d303-4c3f-8582-fb3847c329fe 35 fields · synced May 30, 2026