Identity
- Trade Name
- Gynecological Brachytherapy Kit FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, manual FDA UDI
- Device Name
- Gynecological brachytherapy kit FDA UDI
- Model / Reference
- 7058 FDA UDI
- Description
- Gynecological brachytherapy kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B16570580326073124097 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Vaginal brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal brachytherapy system applicator, manual
Gynecological Brachytherapy Kit by Liberty Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal brachytherapy system applicator, manual.
- BrachyGel Vaginal Hydrogel Packing System — Medtec LLC · Class II
- Interstitial needles — Nucletron B.V. · Class II
- Interstitial needles — Nucletron B.V. · Class II
- Gynecological Template — LIBERTY MEDICAL INC · Class I
- Gynecological Template — LIBERTY MEDICAL INC · Class I
- Gynecological Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
- Central Rod Assembly — LIBERTY MEDICAL INC · Class I
- Gynecological Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Liberty Medical Inc
Sources (1)
- FDA UDI abe23338-c164-464e-80c3-dc46c9f72150 33 fields · synced Jun 1, 2026