Duns Number:961027315
Device Description: Cannulated Tap 6.5mm/7.3mm Cannulated Screws 275mm/200mm tap Depth
Catalog Number
CH05-0001
Brand Name
CARDINAL HEALTH
Version/Model Number
CH05-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 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
-
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
HWX
Product Code Name
TAP, BONE
Public Device Record Key
2abda084-8962-40e3-acee-866b68e4c23f
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
June 05, 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 |