Duns Number:007941230
Device Description: Protector Anesthesia Eye Double Foam Single-Patient Use Adult Plastic Clear Sterile Not Ma Protector Anesthesia Eye Double Foam Single-Patient Use Adult Plastic Clear Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
EP3500
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"
Yes
For Single-Use
Yes
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
HOY
Product Code Name
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Public Device Record Key
78e88479-96d5-4dd7-9109-8057d942541e
Public Version Date
October 28, 2020
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
50885632109988
Quantity per Package
25
Contains DI Package
10885632109980
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |