Duns Number:618214410
Device Description: Durette IV External Laser Eye Shield Replacement Clear Plastic Attachments, NOT AUTOCLAVA Durette IV External Laser Eye Shield Replacement Clear Plastic Attachments, NOT AUTOCLAVABLE....2 sets: incl. 4 nasals + 4 temporals
Catalog Number
OP21-440
Brand Name
Hayden Medical
Version/Model Number
OP21-440
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
IWS
Product Code Name
Shield, eye, radiological
Public Device Record Key
b8e6e1af-74ba-4610-b29f-3947a466843a
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |