Duns Number:367994657
Device Description: Pin kit 2.0 mm (3 pcs)
Catalog Number
OPK-20K3
Brand Name
Inion FreedomPin™
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K133932
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
57d7356e-2b9f-4d5f-bcb7-35ce3fdd528c
Public Version Date
August 29, 2019
Public Version Number
4
DI Record Publish Date
February 07, 2017
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 | 201 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 473 |