FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ-Blade Remover
DI: 08800017901688
·
Model: EZ-Blade Remover
·
DXM CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- EZ-Blade Remover
- Primary DI
- 08800017901688
- Version / Model
- EZ-Blade Remover
- Company Name
- DXM CO., LTD
- Labeler DUNS
- 688797315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- c55a0206-d889-4860-a3c6-8855bc9d0694
Device Description
Disposable Blade Remover is a simple but efficient way to prevent cuts, scrapes, and possible infection when removing and disposing blades with no direct contact with the blade Easily and securely remove used scalpel blades for disposal • Palm-sized round design made with rigid and durable polypropylene • User is able to safely and hygienically remove the blades with one simple pull • Store up to 100 blades • Store not only used scalpel blades but also medical needles, dermaplaning tools, dermaplaning razors, and other small blades
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 08800017901787 | GS1 | ||||
| Primary | 08800017901688 | GS1 |