Duns Number:062388929
Device Description: Full-length, anti-fog, lightweight face shield for bodily fluid splash protection. Not for Full-length, anti-fog, lightweight face shield for bodily fluid splash protection. Not for use in presence of high intensity heat source or flammable gas. Reusable, single-user recommended. Natural rubber latex in head strap.
Catalog Number
5320
Brand Name
Strong Manufacturers
Version/Model Number
5320
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
3ccecc58-c4ce-4ff7-b75a-6aa3909b480e
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 22, 2022
Package DI Number
10850005354755
Quantity per Package
40
Contains DI Package
00850005354758
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |