Duns Number:961027315
Device Description: ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile
Catalog Number
CT5503TS
Brand Name
ChemoPlus
Version/Model Number
CT5503TS
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"
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
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
d41e46bf-048c-45d0-b8fd-b724789cb8be
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
Package DI Number
50885380172425
Quantity per Package
14
Contains DI Package
10885380172427
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 | 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 |