Duns Number:438793622
Device Description: GALAXY TL-HEX CONNECTING POST L100MM D 12MM
Catalog Number
93032
Brand Name
GALAXY FIXATION SYSTEM
Version/Model Number
1
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
K113770
Product Code
KTT
Product Code Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Public Device Record Key
df34a624-c642-4e6f-9ab0-16feb3d45122
Public Version Date
September 17, 2018
Public Version Number
3
DI Record Publish Date
May 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 | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 6371 |