Duns Number:832637081
Device Description: ROD ROTATION WRENCH FOR 6.0MM HEX-END RODS
Catalog Number
03622082
Brand Name
NA
Version/Model Number
03.622.082
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 20, 2017
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
HXC
Product Code Name
WRENCH
Public Device Record Key
8967c1a1-4959-4076-ae33-cc8e924a168b
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
November 08, 2017
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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |