Identity
- Trade Name
- BladeNeedleSYSTEM FDA UDI
- Generic Name
- Bile duct brachytherapy system applicator, manual FDA UDI
- Device Name
- The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles. FDA UDI
- Model / Reference
- QBNS202B-R FDA UDI
- Description
- The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09337363001735 FDA UDI
- FDA Product Code
- GAB FDA UDI
- GMDN Term
- Bile duct brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bile duct brachytherapy system applicator, manual
BladeNeedleSYSTEM by Qlicksmart Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bile duct brachytherapy system applicator, manual.
- BladeCARTRIDGE — QLICKSMART PTY LTD · Class I
- BladeCASSETTE — QLICKSMART PTY LTD · 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
- Qlicksmart Pty Ltd
Sources (1)
- FDA UDI 06af20c7-580c-441d-a194-9c5b849b73bf 34 fields · synced Jun 8, 2026