FDA UDI
In Commercial Distribution
🇺🇸 United States
MediMax Tech
DI: 00817325021791
·
Model: Loop Electrodes LE10-10
·
MEDIMAX TECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediMax Tech
- Primary DI
- 00817325021791
- Version / Model
- Loop Electrodes LE10-10
- Company Name
- MEDIMAX TECH INC.
- Labeler DUNS
- 927071162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 98331972-816e-4027-a88a-f56a681b396a
Device Description
Loop Electrodes LE10-10: Tungsten Loop, 10mmx10mm, 5'', ESU Pencil Accessories
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45633 | Electrocautery system electrode | An active conductor (e.g., blade or loop) that is attached to an electrocautery system handpiece or other surgical instrument (e.g., an endoscopic device) which is heated via the electrical current from the generator and used during surgical intervention to burn or sear body tissue. It is made of an appropriate metal and is typically used to stop bleeding (cauterization of blood vessels) and to treat superficial skin lesions (e.g., removal of warts). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817325021795 | GS1 | Master Case | 10 | In Commercial Distribution | |
| Package | 10817325021798 | GS1 | Inner Box | 5 | In Commercial Distribution | |
| Primary | 00817325021791 | GS1 |
Customer Contacts
- Phone
- 855-633-4629
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143103 | 000 |