Duns Number:081057389
Device Description: ABSORBENT TRAY LINER, 20 IN. X 25 IN. / 51 CM X 64 CM.
Catalog Number
10502
Brand Name
Halyard
Version/Model Number
10502
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2020
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
f133a0d7-0715-40d3-bb46-08f9ab1f9a3c
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
April 21, 2016
Package DI Number
30680651105029
Quantity per Package
8
Contains DI Package
20680651105022
Package Discontinue Date
January 20, 2020
Package Status
Not 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 |