Duns Number:072656713
Device Description: H&H Combat Eye Shield, a sterile product with an aluminum eye shield surrounded by a circl H&H Combat Eye Shield, a sterile product with an aluminum eye shield surrounded by a circle of hydrogel to hold the shield in place without tape or adhesive.
Catalog Number
HHCES01
Brand Name
H&H Combat Eye Sheild
Version/Model Number
1
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
360577d0-da0e-4eb6-88b1-d413c4a176f7
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |