Identity
- Trade Name
- Ovoid pair, mini 16 mm diameter FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- AL07334003 FDA UDI
Identifiers
- Catalog Number
- AL07334003 FDA UDI
- Primary DI / UDI-DI
- 00816389020030 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 16 Millimeter FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Ovoid pair, mini 16 mm diameter 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
- 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
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
- PIVOT SCREW (CT/MR FSD) — Varian Medical Systems Deutschland GmbH
- PIVOT SCREW BTM (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 Deutschland GmbH
Sources (1)
- FDA UDI f6a0c2ba-c0c6-4389-8dae-1b9bb1af1b15 35 fields · synced May 30, 2026