Identity
- Trade Name
- Ovoid mini Ø16 mm Right FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- GM94066720 FDA UDI
Identifiers
- Catalog Number
- GM94066720 FDA UDI
- Primary DI / UDI-DI
- 00810563023015 FDA UDI
- 510(k) Number
- K243939 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Vaginal brachytherapy system applicator, remote-afterloading
Ovoid mini Ø16 mm Right by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vaginal brachytherapy system applicator, remote-afterloading.
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Cleared under the same submission
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 ec5d9ddd-840a-4faf-b5bb-2d59b490414f 34 fields · synced May 30, 2026