FDA UDI
In Commercial Distribution
🇺🇸 United States
BladeFlask EVO Blade Remover
DI: 09337363001780
·
Model: QBVRMOPEC
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BladeFlask EVO Blade Remover
- Primary DI
- 09337363001780
- Version / Model
- QBVRMOPEC
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-27
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 17de0be5-1c74-4c36-aeee-30960a35b00c
Device Description
The Qlicksmart BladeFlask EVO provides a simply safer way to remove used scalpel blades and can accommodate different types of scalpel handles and blades including large autopsy scalpels, thick and round handles, even hexagonal shaped versions - giving you greater freedom in using any scalpel you want. It is so simple to use with just one hand. Embrace safety with the new standard in scalpel blade removals and prevent 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
- Yes
- 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 |
|---|---|---|---|---|
| GES | Blade, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
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 | 09337363001780 | GS1 | ||||
| Package | 29337363001784 | GS1 | 24 | In Commercial Distribution |