Eli Ezer - Screen Projector Ezer EDC-2600 - U.S. OPHTHALMIC, L.L.C.

Duns Number:166760392

Device Description: Screen Projector Ezer EDC-2600

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Eli Ezer

Version/Model Number

EDC-2600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

HOX

Product Code Name

Chart, Visual Acuity

Device Record Status

Public Device Record Key

a7dc4866-c7ec-4b09-804f-871b1231f2a6

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

October 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"U.S. OPHTHALMIC, L.L.C." Characteristics
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