Duns Number:602465783
Device Description: Cannulated Anti-torque Standard/Hightop
Catalog Number
-
Brand Name
OsseoScrew
Version/Model Number
62922-HT
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"
-
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
c5eb97a2-bd35-4f52-aab4-e55f051a7048
Public Version Date
January 07, 2020
Public Version Number
1
DI Record Publish Date
December 30, 2019
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 | 5644 |
2 | A medical device with a moderate to high risk that requires special controls. | 26570 |
U | Unclassified | 15 |