FDA UDI
In Commercial Distribution
🇺🇸 United States
BladeCARTRIDGE-1
DI: 09337363000851
·
Model: QSSVCAT-1B
·
QLICKSMART PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
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Basic Information
- Brand Name
- BladeCARTRIDGE-1
- Primary DI
- 09337363000851
- Version / Model
- QSSVCAT-1B
- Company Name
- QLICKSMART PTY LTD
- Labeler DUNS
- 755003498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2017-08-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5f451302-3f41-470d-9753-1b4a6b24fde9
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
- Yes
- Sterilization Methods
- Radiation Sterilization, Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Primary | 09337363000851 | GS1 | ||||
| Unit of Use | 09337363001469 | GS1 |