Identity
- Trade Name
- BladeFLASK FDA UDI
- Generic Name
- Scalpel blade remover FDA UDI
- Device Name
- Qlicksmart BladeFLASK provides a simply safer way to remove and contain used scalpel blades. This world-first single-handed scalpel blade remover prevents the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing. FDA UDI
- Model / Reference
- QFRUSAMOPEC FDA UDI
- Description
- Qlicksmart BladeFLASK provides a simply safer way to remove and contain used scalpel blades. This world-first single-handed scalpel blade remover prevents the dangerous injuries commonly caused by removing blades with fingers, forceps or re-sheathing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09337363001223 FDA UDI
- 510(k) Number
- K983367 FDA UDI
- FDA Product Code
- MMK FDA UDI
- GMDN Term
- Scalpel blade remover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalpel blade remover
BladeFLASK by Qlicksmart Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel blade remover.
- Sklar — Sklar Corporation · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- gSource — GSOURCE, LLC. · Class I
- EZ-Blade Remover — DXM CO., LTD · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- REMOVER — KLS-Martin L.P. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
Cleared under the same submission
K983367 also covers:
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
- Qlicksmart Pty Ltd
Sources (1)
- FDA UDI 68736424-4d6c-485a-99ac-854027330ca7 34 fields · synced May 30, 2026