Duns Number:196548481
Device Description: Zippered Toga with Peel Away Face Shield
Catalog Number
0416-851-100
Brand Name
T7Plus
Version/Model Number
0416-851-100
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
K200493,K200493
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
fa1a17e6-3ebf-4739-a140-50f4f272ce31
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
May 11, 2020
Package DI Number
37613327466134
Quantity per Package
8
Contains DI Package
07613327466133
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 |