Duns Number:196548481
Device Description: Zippered Toga
Catalog Number
0416-851-200
Brand Name
T7Plus
Version/Model Number
0416-851-200
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
462cf587-485c-45ec-9850-3b564b145c32
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
May 14, 2020
Package DI Number
37613327466110
Quantity per Package
8
Contains DI Package
07613327466119
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 |