Duns Number:277373213
Device Description: Stereomicroscopic observation of the eye subjected to light through a slotMicroscopic stud Stereomicroscopic observation of the eye subjected to light through a slotMicroscopic study of the fundus and posterior vitreous (via a lens Hubry)The ophthalmic evaluation and positioning of the contact lensThis product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
Catalog Number
-
Brand Name
ESSILOR SL550L
Version/Model Number
SL550L
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
85c380bc-60c0-4de2-abbb-84fbe9348377
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |