Duns Number:081057389
Device Description: AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, L
Catalog Number
44670NS
Brand Name
Halyard
Version/Model Number
44670
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
-
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
9c314e17-3f10-4f24-baf6-ea53df697184
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
March 18, 2020
Package DI Number
30680651446702
Quantity per Package
12
Contains DI Package
20680651446705
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 |