FDA UDI
In Commercial Distribution
🇺🇸 United States
BladeCASSETTE
DI: 19337363001589
·
Model: QSSVCAS-3R
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- BladeCASSETTE
- Primary DI
- 19337363001589
- Version / Model
- QSSVCAS-3R
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-09-12
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- b67fa766-f460-41c8-b2c1-86439f057f97
Device Description
The BladeCASSETTE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades.Used together with a hands-free passing technique, the Qlicksmart BladeCASSETTE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle. Qlicksmart BladeCASSETTE scalpel blade remover is award-winning, which demonstrate its practicality and effectiveness in reducing scalpel injuries.
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 |
|---|---|---|---|---|
| 46236 | Scalpel blade remover, sterile | A sterile device used to safely remove and contain one scalpel blade from a reusable scalpel handle without compromising the sterility of a surgical field. It is typically a sealed plastic cartridge into which a scalpel is pushed, and where an internal configuration transforms this linear motion into a lateral force that lifts the heel (rear portion) of the scalpel blade from the tang of the handle, and a reverse linear motion (pulling the scalpel handle out) removes the blade from the tang; the blade is retained within the container. This device may have a dedicated holder and is typically used in surgical facilities. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 29337363001586 | GS1 | Outer Carton | 4 | In Commercial Distribution | |
| Primary | 19337363001589 | GS1 | ||||
| Unit of Use | 09337363001582 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Avoid direct exposure to sunlight