FDA UDI
In Commercial Distribution
🇺🇸 United States
DawnMist
DI: 10665973012862
·
Model: PR01
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- DawnMist
- Primary DI
- 10665973012862
- Version / Model
- PR01
- Catalog Number
- PR01
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 163dadf2-1088-4d23-a56a-25fa8dca4457
Device Description
Prep Razor Blue Hndl Plast Grd
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 20665973012869 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10665973012862 | GS1 | ||||
| Unit of Use | 00665973012865 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]