Duns Number:081057389
Device Description: Femoral Angiography Drape with Window 82 in. x 130 in. / 208 cm x 330 cm - Handi-Bin
Catalog Number
79109
Brand Name
Halyard
Version/Model Number
79109
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
9dbd3356-a1f6-4975-8481-1680337797b9
Public Version Date
October 15, 2019
Public Version Number
1
DI Record Publish Date
October 07, 2019
Package DI Number
30680651791093
Quantity per Package
20
Contains DI Package
20680651791096
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 |