Duns Number:117630237
Device Description: Galen Small Joint Anchor 3.3mm x 10mm, Size 2, MO6 Needles, Peek
Catalog Number
-
Brand Name
Galen Small Joint Anchor
Version/Model Number
F-08-11108
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
Yes
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
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
476a36ca-7b47-4aa7-bf53-e076cc911523
Public Version Date
May 18, 2022
Public Version Number
1
DI Record Publish Date
May 10, 2022
Package DI Number
10818614022496
Quantity per Package
5
Contains DI Package
00818614022499
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 162 |