FDA UDI
In Commercial Distribution
🇺🇸 United States
BladeFLASK
DI: 09337363001216
·
Model: QFRGEN-01
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BladeFLASK
- Primary DI
- 09337363001216
- Version / Model
- QFRGEN-01
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-24
- Public Version
- 4
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 058a6777-262e-458f-9b46-0d0eab77ab86
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMK | Container, Sharps | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46235 | Scalpel blade remover | A non-powered device intended to be used to safely remove and contain scalpel blades from reusable scalpel handles after use. It is typically a sealed container into which a scalpel is pushed, whereby an internal mechanism detaches the blade from the handle; the blade is retained within the container. This device may be used in a clinical or laboratory setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09337363001216 | GS1 | ||||
| Package | 19337363001213 | GS1 | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983367 | 000 |