Duns Number:042961576
Device Description: 12 x 6 Subtalar Trial
Catalog Number
PST-1206
Brand Name
Baby Gorilla/Gorilla Plating System
Version/Model Number
PST-1206
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
HWT
Product Code Name
TEMPLATE
Public Device Record Key
abee0257-6db2-4c64-b1af-778f57b01014
Public Version Date
October 25, 2019
Public Version Number
1
DI Record Publish Date
October 17, 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 | 1122 |
2 | A medical device with a moderate to high risk that requires special controls. | 3564 |