Duns Number:961027315
Device Description: STRL BURN UNIT DEBRIDE GRAFT
Catalog Number
SER42BGUKM
Brand Name
CARDINAL HEALTH
Version/Model Number
SER42BGUKM
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJJ
Product Code Name
Burn kit without drug
Public Device Record Key
6a01a0b2-5978-4319-b662-6d61b0981ad5
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 21, 2017
Package DI Number
50887488800378
Quantity per Package
1
Contains DI Package
10887488800370
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 |