Duns Number:081057389
Device Description: HYH SPECIALTY DRAPE
Catalog Number
-
Brand Name
Halyard
Version/Model Number
90722
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
KKX
Product Code Name
Drape, surgical
Public Device Record Key
d97b7b36-dc02-45f0-9dd9-b09f67051cb5
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
April 15, 2016
Package DI Number
30680651907227
Quantity per Package
14
Contains DI Package
10680651907223
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 |