Duns Number:081057389
Device Description: HALYARD* Standard Back Table Cover-No-44 x 88-44 x 88-Flat Fold-Individually Wrapped-28-1- HALYARD* Standard Back Table Cover-No-44 x 88-44 x 88-Flat Fold-Individually Wrapped-28-1-28
Catalog Number
42301-02
Brand Name
Halyard
Version/Model Number
42301
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
K083234,K083234
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
f7add92b-d8aa-4a78-a9ea-f02b879d5876
Public Version Date
October 17, 2018
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
30680651423017
Quantity per Package
28
Contains DI Package
10680651423013
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 |