FDA UDI
In Commercial Distribution
🇺🇸 United States
SourceMark
DI: 00813799006739
·
Model: SMBLADEUF
·
SOURCEMARK, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SourceMark
- Primary DI
- 00813799006739
- Version / Model
- SMBLADEUF
- Company Name
- SOURCEMARK, LLC.
- Labeler DUNS
- 121225812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-21
- Public Version
- 1
- Public Version Date
- 2020-07-29
- Public Version Status
- New
- Public Device Record Key
- a31180a6-8ab5-48f3-9854-674985530af9
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 35097 | Surgical hair clippers | A hand-held electrically-powered device designed for removing long hair from the head or body of a patient prior to surgery/treatment. The device is typically operated by a healthcare professional. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813799006743 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00813799006739 | GS1 |