Identity
- Trade Name
- BladeNeedleSYSTEM FDA UDI
- Generic Name
- Scalpel blade remover, sterile 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
- QBNS202S-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
- 09337363001681 FDA UDI
- FDA Product Code
- GAB FDA UDI
- GMDN Term
- Scalpel blade remover, sterile 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
Yes
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
Radiation Sterilization FDA UDI
Category: Scalpel blade remover, sterile
BladeNeedleSYSTEM by Qlicksmart Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel blade remover, sterile.
- BladeCASSETTE — QLICKSMART PTY LTD · Class I
- BladeCASSETTE — QLICKSMART PTY LTD · Class I
- BladeCARTRIDGE-1 — QLICKSMART PTY LTD · Class I
- BladeSINGLE — QLICKSMART PTY LTD · Class I
- BladeSINGLE — QLICKSMART PTY LTD · Class I
- BladeNeedleSYSTEM — QLICKSMART PTY LTD · Class I
- BladeNeedleSYSTEM — QLICKSMART PTY LTD · Class I
- BladeCARTRIDGE-1 — 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 2c162c3f-1b22-4aa9-9af1-a9de42b6b440 34 fields · synced May 30, 2026