Duns Number:081057389
Device Description: ULTRA Film-Reinforced Specialty Gown, XX-Large, with Polypropylene Fabric and Towel
Catalog Number
-
Brand Name
Halyard
Version/Model Number
95531
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080795,K080795
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
777ef49c-b343-422e-8d84-62f6257cb81f
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
April 15, 2016
Package DI Number
30680651955310
Quantity per Package
28
Contains DI Package
10680651955316
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |