Duns Number:003687733
Device Description: Gown, BarrierTech, White, Full Coverage with Banded Ties, Elastic Wrist, UNIV
Catalog Number
GN-22524-3
Brand Name
Critical Cover
Version/Model Number
GN-22524-3
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FME
Product Code Name
Gown, Examination
Public Device Record Key
cd4b3865-dfb1-4685-a2a1-820a8a991f4c
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 21, 2020
Package DI Number
20817583022596
Quantity per Package
1
Contains DI Package
10817583022599
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |