Duns Number:942377524
Device Description: The Bow Tie Reamer Caddy contains non-cannulated bowtie reamers and cannulated bowtie rea The Bow Tie Reamer Caddy contains non-cannulated bowtie reamers and cannulated bowtie reamers to assist with the Fin-Lock glenoid.
Catalog Number
-
Brand Name
TITAN™
Version/Model Number
TITANBOWTIEIMP
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
9136b79b-781c-4988-a165-be91ebdedf9c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 19, 2016
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 | 1909 |
2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
3 | A medical device with high risk that requires premarket approval | 12 |
U | Unclassified | 15 |