Duns Number:166760392
Device Description: Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery an Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC power
Catalog Number
-
Brand Name
Eli Ezer
Version/Model Number
EZ-WOT-2600 DC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
ed985006-25ab-4b4f-8376-9634716328d6
Public Version Date
April 30, 2018
Public Version Number
1
DI Record Publish Date
March 28, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |