Duns Number:961027315
Device Description: Surgical Cap with ElasticExtended Coverage- XL
Catalog Number
4370
Brand Name
CARDINAL HEALTH
Version/Model Number
4370
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
FYF
Product Code Name
CAP, SURGICAL
Public Device Record Key
30bbab09-2151-4f3b-beb7-65e8ac8575c7
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 05, 2019
Package DI Number
50885380161207
Quantity per Package
6
Contains DI Package
20885380161206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |