Duns Number:961027315
Device Description: Three Quarter Sheet-Reinforced, Nonsterile, 56 x 77 in. (142 x195cm), with absorbent reinf Three Quarter Sheet-Reinforced, Nonsterile, 56 x 77 in. (142 x195cm), with absorbent reinforcement, 25 x 42 in. (63 x 106cm)
Catalog Number
29350NC
Brand Name
CARDINAL HEALTH
Version/Model Number
29350NC
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)
Yes
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
66821ef0-a017-4caa-919f-b7954947e169
Public Version Date
February 22, 2019
Public Version Number
1
DI Record Publish Date
January 22, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |