Duns Number:081057389
Device Description: ORTHO PACK IX - LOWER EXTREMITY DRAPE
Catalog Number
-
Brand Name
Halyard
Version/Model Number
88439
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"
Yes
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
04b59b57-cf5e-45aa-adf3-466a6124e537
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
December 15, 2015
Package DI Number
30680651884399
Quantity per Package
6
Contains DI Package
10680651884395
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |