Duns Number:257382580
Device Description: Durette® II External laser shields are designed to protect patient's eyes during laser tre Durette® II External laser shields are designed to protect patient's eyes during laser treatment. They are installed on the face over the eyelids. It is provided with a fastening system that fits as many people as possible. The regular size is used in most treatments on the face, while the small size is used when the surgeon wants to go closer to the eyes. The entire surface of the device is non-glare treated to diffuse the laser. The medical staff uses the instrument during surgery. It must be cleaned and sterilized before use.
Catalog Number
-
Brand Name
Durette® II, SS External Ocular Laser Shields, small (non glare)
Version/Model Number
21-334
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)
Yes
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
IWS
Product Code Name
Shield, Eye, Radiological
Public Device Record Key
c75f4d65-2a31-478a-8b45-d15f3772b794
Public Version Date
November 15, 2019
Public Version Number
1
DI Record Publish Date
November 07, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |