FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Prep Razors
DI: 00616784425122
·
Model: 4251
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Disposable Prep Razors
- Primary DI
- 00616784425122
- Version / Model
- 4251
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-11-02
- Public Version
- 1
- Public Version Date
- 2020-11-10
- Public Version Status
- New
- Public Device Record Key
- 85151a3f-35a5-4621-9926-4155bde20547
Device Description
Disposable Prep 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 | 00616784425115 | GS1 | ||||
| Primary | 00616784425122 | GS1 | ||||
| Package | 00616784425139 | GS1 | 5 | In Commercial Distribution |