Duns Number:961027315
Device Description: Insta-Gard Surgical Mask, Blue
Catalog Number
AT71035
Brand Name
CONVERTORS
Version/Model Number
AT71035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2025
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
FXX
Product Code Name
Mask, surgical
Public Device Record Key
95e8bf64-93fa-450a-ab96-d0a95c8da7ad
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
July 06, 2016
Package DI Number
50885380012462
Quantity per Package
6
Contains DI Package
20885380072021
Package Discontinue Date
January 01, 2025
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |