Identity
- Trade Name
- Brachytherapy Kit FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, manual FDA UDI
- Device Name
- (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk (1) 5910- buttons, 5/pk, assorted colors FDA UDI
- Model / Reference
- 5642 FDA UDI
- Description
- (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk (1) 5910- buttons, 5/pk, assorted colors FDA UDI
Identifiers
- Primary DI / UDI-DI
- B16556480326083124112 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Prostate 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
Dimensions & Sizes
- Size
- Needle Gauge — 15 Gauge FDA UDI
Category: Prostate brachytherapy system applicator, manual
Brachytherapy Kit by Liberty Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 32fa887f-7342-461b-9a0c-bc24afb1451d 34 fields · synced May 30, 2026