FDA UDI
In Commercial Distribution
🇺🇸 United States
BladeNeedleSYSTEM
DI: 09337363001735
·
Model: QBNS202B-R
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BladeNeedleSYSTEM
- Primary DI
- 09337363001735
- Version / Model
- QBNS202B-R
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-27
- Public Version
- 1
- Public Version Date
- 2019-12-05
- Public Version Status
- New
- Public Device Record Key
- 06af20c7-580c-441d-a194-9c5b849b73bf
Device 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.
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38422 | Bile duct brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bile duct. It is an individual device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bile duct. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes bile duct applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 29337363001739 | GS1 | Carton | 144 | In Commercial Distribution | |
| Primary | 09337363001735 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and avoid direct exposure to sunlight