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Varian Universal Titanium Cervix Probe Set, even lengths
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Varian Universal Titanium Cervix Probe Set, even lengths FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11013100 FDA UDI
Identifiers
- Catalog Number
- GM11013100 FDA UDI
- Primary DI / UDI-DI
- 00816389027619 FDA UDI
- 510(k) Number
- K172611 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 Unsafe FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Varian Universal Titanium Cervix Probe Set, even lengths 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
K172611 also covers:
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 30mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 40mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 60mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 70mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 80mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 30mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 40mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 50mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 60mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 70mm — Varian Medical Systems Deutschland GmbH
- Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 30 degree, 80mm — 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 e4270ed0-75ae-4152-91d6-64f29f857d68 34 fields · synced May 30, 2026