FDA UDI
In Commercial Distribution
🇺🇸 United States
GlobTek
DI: 00859626006121
·
Model: ML-830-02-004
·
MICROLIGHT CORPORATION OF AMERICA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GlobTek
- Primary DI
- 00859626006121
- Version / Model
- ML-830-02-004
- Catalog Number
- ML-830-02-004
- Company Name
- MICROLIGHT CORPORATION OF AMERICA
- Labeler DUNS
- 137829417
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 4
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- d3493557-09da-4e2b-aaf1-754d4735b27e
Device Description
Transformer with Output Cord
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| NHN | Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36800 | Isolation transformer | A device designed to be used in a mains electricity alternating current (AC) circuit to increase (step-up) or decrease (step-down) voltage, to provide the specified voltage to a parent device; it is not a built-in component of the parent device. It provides isolation between the mains current and the parent device for safety, and has separate primary (input) and secondary (output) coils. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859626006121 | GS1 |
Customer Contacts
- Phone
- 281-433-4648
- [email protected]