Identity
- Trade Name
- Clamping ring for cylinders FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- for adjustable holder for Cylinder Type Applicator Sets FDA UDI
- Model / Reference
- GM11001810 FDA UDI
- Description
- for adjustable holder for Cylinder Type Applicator Sets FDA UDI
Identifiers
- Catalog Number
- GM11001810 FDA UDI
- Primary DI / UDI-DI
- 00816389022027 FDA UDI
- 510(k) Number
- K952913 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
Category: Vaginal brachytherapy system applicator, remote-afterloading
Clamping ring for cylinders by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
- Smit cervical sleeve 40 mm, with clamping for guiding tube — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 30 degrees, 70 mm — Varian Medical Systems Deutschland GmbH · Class II
- Front segment open 35 mm diameter, straight, length 60 mm — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe 3mm diameter x 320 mm, straight — Varian Medical Systems Deutschland GmbH · Class II
- Surface cone inset, ø20 mm, round — Varian Medical Systems Deutschland GmbH · Class II
- 5 cm intrauterine probe angled 20 degrees, for 3-channel applicator — Varian Medical Systems Deutschland GmbH · Class II
- Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm — Varian Medical Systems Deutschland GmbH · Class II
- Marking screw, 180 degrees, shielded — Varian Medical Systems Deutschland GmbH · Class II
Cleared under the same submission
K952913 also covers:
- 4.7 Fr. metal-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH
- 4.7 Fr. metal-tipped catheter, 150 cm — Varian Medical Systems Deutschland GmbH
- 4.7 Fr. plastic-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH
- 4.7 Fr. plastic-tipped catheter, 150 cm — Varian Medical Systems Deutschland GmbH
- APPLICATOR WRENCH (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- CERVICAL STOP (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- CLAMP SPREAD BLOCK (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- Measurement marker clip — Varian Medical Systems Deutschland GmbH
- Ovoid pair, 20 mm diameter — Varian Medical Systems Deutschland GmbH
- Ovoid pair, 25 mm diameter — Varian Medical Systems Deutschland GmbH
- Ovoid pair, mini 16 mm diameter — Varian Medical Systems Deutschland GmbH
- PIVOT SCREW (CT/MR FSD) — 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, Inc
Sources (1)
- FDA UDI af84c6fd-2790-4f50-8d18-3b0bf5981084 35 fields · synced Jun 8, 2026