Identity
- Trade Name
- Tool for vaginal cylinders FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11002800 FDA UDI
Identifiers
- Catalog Number
- GM11002800 FDA UDI
- Primary DI / UDI-DI
- 00816389022324 FDA UDI
- 510(k) Number
- K033371 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Tool for vaginal cylinders 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
K033371 also covers:
- Applicator probe 6/3 mm diameter, curved 20 degrees, length 320 mm — Varian Medical Systems Deutschland GmbH
- Basic Accessory Kit for Intracavitary/GYN Applicators, GammaMed — Varian Medical Systems Deutschland GmbH
- Basic accessory kit for intracavitary / GYN applicators, VariSource — Varian Medical Systems Deutschland GmbH
- CT vaginal stump cylinder, 20 mm diameter, with plastic clamping screw — Varian Medical Systems Deutschland GmbH
- CT vaginal-stump cylinder, 23 mm diameter, with plastic clamping screw — Varian Medical Systems Deutschland GmbH
- CT vaginal-stump cylinder, 26 mm diameter, with plastic clamping screw — Varian Medical Systems Deutschland GmbH
- CT vaginal-stump cylinder, 30 mm diameter, with plastic clamping screw — Varian Medical Systems Deutschland GmbH
- CT vaginal-stump cylinder, 35 mm diameter, with plastic clamping screw — Varian Medical Systems Deutschland GmbH
- Cervical sleeve 30 mm, with clamp for guide tube — Varian Medical Systems Deutschland GmbH
- Cervical sleeve 50 mm, with clamp for guide tube — Varian Medical Systems Deutschland GmbH
- Cervical sleeve 70 mm, with clamp for guide tube — Varian Medical Systems Deutschland GmbH
- Closed CT vaginal-cylinder, 20 mm diameter, with plastic clamping screw — 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 9664592b-f29d-4205-822c-77090516a245 34 fields · synced May 30, 2026