Duns Number:081057389
Device Description: HALYARD BASICS* Laparotomy Drape
Catalog Number
79227
Brand Name
Halyard
Version/Model Number
79227
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
0a9e235e-5a07-49b4-ad8c-54060d36eb40
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2019
Package DI Number
30680651792274
Quantity per Package
30
Contains DI Package
10680651792270
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 |