FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Scalpel
DI: 00620974002215
·
Model: 73-0120
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Disposable Scalpel
- Primary DI
- 00620974002215
- Version / Model
- 73-0120
- Catalog Number
- 73-0120
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-10-02
- Public Version
- 1
- Public Version Date
- 2020-10-12
- Public Version Status
- New
- Public Device Record Key
- 5033e85f-e1c1-4a49-972b-c2fdf6007da5
Device Description
#20 Sterile Disposable Scalpel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GES | BLADE, SCALPEL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10620974002212 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00620974002215 | GS1 | ||||
| Unit of Use | 20620974002219 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]