Duns Number:196884852
Device Description: 2 mm X 50 mm Tension Band Pin
Catalog Number
-
Brand Name
ACUMED
Version/Model Number
30-0166
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
K964500
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
fe9ede85-50e1-4398-8b71-1a67b4b18a4b
Public Version Date
April 22, 2019
Public Version Number
4
DI Record Publish Date
October 24, 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 | 1870 |
2 | A medical device with a moderate to high risk that requires special controls. | 4532 |