Identity
- Trade Name
- Surface cone inset, ø20 mm, round FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM11003680 FDA UDI
Identifiers
- Catalog Number
- GM11003680 FDA UDI
- Primary DI / UDI-DI
- 00810563021950 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
Yes
FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Surface cone inset, ø20 mm, round by Varian Medical Systems Deutschland GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
K162018 also covers:
- Shielding for cone, 10-25 mm diameter, with fixation — Varian Medical Systems Deutschland GmbH
- Shielding for cone, 30-45 mm diameter, with fixation — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 15 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 25 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 30 diameter x 20 mm, oval — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 30 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 35 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 40 mm diameter, round — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 45 diameter x 25 mm, oval — Varian Medical Systems Deutschland GmbH
- Surface cone inset, 45 mm diameter, round — Varian Medical Systems Deutschland GmbH
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 0f50dfde-371f-4d0b-8752-1d9567042158 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026