Duns Number:961027315
Device Description: Cover Gown; Universal; Over the Head; Yellow; With Thumbhooks
Catalog Number
2110PG
Brand Name
CARDINAL HEALTH
Version/Model Number
2110PG
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
ff9af6d5-b22a-46bc-9a3c-408fa27317b8
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 04, 2018
Package DI Number
50885380013469
Quantity per Package
4
Contains DI Package
20885380013468
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 |