Identity
- Trade Name
- Shielded cylinder, 20 mm diameter FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11003380 FDA UDI
Identifiers
- Catalog Number
- GM11003380 FDA UDI
- Primary DI / UDI-DI
- 00816389022577 FDA UDI
- 510(k) Number
- K151657 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
Dimensions & Sizes
- Size
- Outer Diameter — 20 Millimeter FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Shielded cylinder, 20 mm diameter by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K151657 also covers:
- Applicator probe 3mm diameter x 320 mm, straight — Varian Medical Systems Deutschland GmbH
- Clamping nut for marking screw — Varian Medical Systems Deutschland GmbH
- Clamping screw for probe 3 mm — Varian Medical Systems Deutschland GmbH
- Marking screw, 0 degrees shielded — Varian Medical Systems Deutschland GmbH
- Marking screw, 180 degrees, shielded — Varian Medical Systems Deutschland GmbH
- Marking screw, 2 x 90 degrees, shielded — Varian Medical Systems Deutschland GmbH
- Marking screw, 270 degrees, shielded — Varian Medical Systems Deutschland GmbH
- Marking screw, 90 degrees shielded — Varian Medical Systems Deutschland GmbH
- Plexiglas filler piece 90 degrees — Varian Medical Systems Deutschland GmbH
- Shielded Applicator Set — Varian Medical Systems Deutschland GmbH
- Shielded cylinder, 23 mm diameter — Varian Medical Systems Deutschland GmbH
- Shielded cylinder, 26 mm diameter — 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 b8ad5f99-82eb-43d5-9e4a-30c0e5510c86 35 fields · synced May 30, 2026