Duns Number:961027315
Device Description: 2.7mm Cortex Screw Self-Tapping with T8 Recess 48mm Material: 316L Stainless Steel
Catalog Number
S2C27T48
Brand Name
CARDINAL HEALTH
Version/Model Number
S2C27T48
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2018
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"
-
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
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
71500b39-40cd-4611-9434-a40632e9d534
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
June 08, 2018
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 |