FDA UDI
In Commercial Distribution
🇺🇸 United States
Twin Blade Razors
DI: 00616784425016
·
Model: 4250
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- Twin Blade Razors
- Primary DI
- 00616784425016
- Version / Model
- 4250
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-01
- Public Version
- 1
- Public Version Date
- 2020-11-09
- Public Version Status
- New
- Public Device Record Key
- 5e9fb56e-d6b5-406d-8993-4ad9b85a7816
Device Description
Disposable Twin Blade Razors
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 |
|---|---|---|---|---|
| LWK | Razor, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37520 | Safety razor, single-use | A hand-held device fitted with an integral razor blade used to remove facial or body hair from a person or patient. It is known as a safety razor because the blade lies protected within the razor head leaving only the cutting edge exposed. This device can be used for skin preparation prior to treatment/surgical intervention or for normal grooming. 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 | 00616784425009 | GS1 | ||||
| Primary | 00616784425016 | GS1 | ||||
| Package | 00616784425023 | GS1 | 5 | In Commercial Distribution | ||
| Package | 00616784425030 | GS1 | 6 | In Commercial Distribution |