FDA UDI
In Commercial Distribution
🇺🇸 United States
Enova Illumination
DI: 00850025993302
·
Model: 80102-001
·
Enova Illumination, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enova Illumination
- Primary DI
- 00850025993302
- Version / Model
- 80102-001
- Company Name
- Enova Illumination, Inc.
- Labeler DUNS
- 080805136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-27
- Public Version
- 1
- Public Version Date
- 2022-02-04
- Public Version Status
- New
- Public Device Record Key
- 7b7cc4f6-073a-473d-998b-2a95d0fed080
Device Description
PP Mobile Battery Charger
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | 886.4335 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850025993302 | GS1 |