Duns Number:961027315
Device Description: CRICO TRAY
Catalog Number
17-0585B
Brand Name
CARDINAL HEALTH
Version/Model Number
17-0585B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OGP
Product Code Name
Cricothyrotomy kit
Public Device Record Key
7adfa2e5-e5cd-4c2b-aa42-b80ec70bff5d
Public Version Date
July 23, 2019
Public Version Number
1
DI Record Publish Date
July 15, 2019
Package DI Number
50888439476604
Quantity per Package
15
Contains DI Package
10888439476606
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 |