Duns Number:081057389
Device Description: C-Section Drape with Attached Leggings 116 in. x 125 in. / 294 cm x 317 cm - Handi-Bin
Catalog Number
76353
Brand Name
Halyard
Version/Model Number
76353
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
511e512a-ea60-4f8e-a5e1-7a3ba3d39595
Public Version Date
October 15, 2019
Public Version Number
1
DI Record Publish Date
October 07, 2019
Package DI Number
30680651763533
Quantity per Package
16
Contains DI Package
20680651763536
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 |