Duns Number:249008772
Device Description: Single-use face shield is intended to be worn by personnel during medical procedures to pr Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer
Catalog Number
5300
Brand Name
I-MED Single Use Face Mask
Version/Model Number
5300
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)
-
Over the Counter (OTC)
Yes
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
de2ba942-101d-48d3-9669-94162f103b4b
Public Version Date
October 05, 2022
Public Version Number
2
DI Record Publish Date
June 18, 2020
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 | 5 |