Duns Number:196548481
Device Description: T5 Zipper Toga with Peel-Away Face Shield, (L/XL)
Catalog Number
0400820100
Brand Name
NA
Version/Model Number
0400820100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
c2ac6ba9-d4f1-42ef-a03d-4f3eedd4649f
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
34546540502675
Quantity per Package
10
Contains DI Package
04546540502674
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |