Duns Number:438793622
Device Description: Guided growth D.4.5 mm L.32 mm cannulated ss screw full thread, non sterile
Catalog Number
GPS432CE
Brand Name
Guided Growth Plate 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
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
K110805
Product Code
OBT
Product Code Name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Public Device Record Key
a6cfc8ef-4c38-40f9-8931-0c13f8ac2877
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 10, 2015
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 |