Identity
- Trade Name
- Thumbscrew for Kelowna GYN templates FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11012320 FDA UDI
Identifiers
- Catalog Number
- GM11012320 FDA UDI
- Primary DI / UDI-DI
- 00816389020153 FDA UDI
- 510(k) Number
- K162533 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
Thumbscrew for Kelowna GYN templates 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
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- 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
K162533 also covers:
- Adapter pin for Kelowna GYN templates — Varian Medical Systems Deutschland GmbH
- Blue locking collets for 2.0mm needles (pack of 25) — Varian Medical Systems Deutschland GmbH
- Crook Prostate Template 17 G B&K — Varian Medical Systems Deutschland GmbH
- Crook Prostate Template 2.0mm B&K — Varian Medical Systems Deutschland GmbH
- Crook Prostate Template 2.0mm Siemens — Varian Medical Systems Deutschland GmbH
- Crook Prostate Templates 17 G Siemens — Varian Medical Systems Deutschland GmbH
- Kelowna GYN Template 16 G — Varian Medical Systems Deutschland GmbH
- Kelowna GYN Template 17 G — Varian Medical Systems Deutschland GmbH
- Kelowna GYN Template 2, 0mm — Varian Medical Systems Deutschland GmbH
- Locking Collets for 16G and 17G needles (pack of 25) — 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 0f7e3a2a-0a25-40a5-b7c1-60a6f1d585ea 34 fields · synced Jun 1, 2026