FDA UDI
In Commercial Distribution
🇺🇸 United States
Oak Ridge Products
DI: 00852482006823
·
Model: 0701-5800
·
OAKRIDGE PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Oak Ridge Products
- Primary DI
- 00852482006823
- Version / Model
- 0701-5800
- Company Name
- OAKRIDGE PRODUCTS, LLC
- Labeler DUNS
- 111322165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-20
- Public Version
- 1
- Public Version Date
- 2023-09-28
- Public Version Status
- New
- Public Device Record Key
- 149fc314-71c9-48c6-994e-f7ccd84f9c57
Device Description
This Shave Prep Razor is a double sided razor made for the preparation of a patient. Color: Black Body Length: 92.5 mm Body width: 44.0 mm
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
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00852482006823 | GS1 | ||||
| Package | 10852482006820 | GS1 | 100 | In Commercial Distribution |