FDA UDI
In Commercial Distribution
🇺🇸 United States
Eli Ezer
DI: 00851158007522
·
Model: EZ-WOT-2600 DC
·
U.S. OPHTHALMIC, L.L.C.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eli Ezer
- Primary DI
- 00851158007522
- Version / Model
- EZ-WOT-2600 DC
- Company Name
- U.S. OPHTHALMIC, L.L.C.
- Labeler DUNS
- 166760392
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-28
- Public Version
- 1
- Public Version Date
- 2018-04-30
- Public Version Status
- New
- Public Device Record Key
- ed985006-25ab-4b4f-8376-9634716328d6
Device Description
Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC power
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EPY | Speculum, Ent | General, Plastic Surgery | 878.1800 | 1 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | 886.1570 | 2 |
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45085 | ENT diagnostic set | A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851158007522 | GS1 |