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Flexible applicator probe 3.2 mm diameter, braced PVDF
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Flexible applicator probe 3.2 mm diameter, braced PVDF FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11002560 FDA UDI
Identifiers
- Catalog Number
- GM11002560 FDA UDI
- Primary DI / UDI-DI
- 00816389022249 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
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
Category: Vaginal brachytherapy system applicator, remote-afterloading
Flexible applicator probe 3.2 mm diameter, braced PVDF 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.
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- 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 1d06ad3c-89ae-4adc-9793-ab84e4535e56 34 fields · synced May 30, 2026