Duns Number:961027315
Device Description: LAB JACKET CARDINAL HEALTH THREE-LAYER SMS X-LARGE HIP LENGTH SNAP CLOSURE KNIT COLLAR POC LAB JACKET CARDINAL HEALTH THREE-LAYER SMS X-LARGE HIP LENGTH SNAP CLOSURE KNIT COLLAR POCKET
Catalog Number
C3630RBXL
Brand Name
CARDINAL HEALTH
Version/Model Number
C3630RBXL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 26, 2023
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
LYU
Product Code Name
ACCESSORY, SURGICAL APPAREL
Public Device Record Key
7c8139ea-0a48-4670-89d8-670c31ef5675
Public Version Date
June 28, 2021
Public Version Number
2
DI Record Publish Date
April 30, 2019
Package DI Number
50885380167858
Quantity per Package
10
Contains DI Package
20885380167857
Package Discontinue Date
June 26, 2023
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 |