Duns Number:109903521
Device Description: STNM PIN TRO PT ONE END 9/64X9 NS
Catalog Number
72204575
Brand Name
N/A
Version/Model Number
72204575
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863734,K863734
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
ec8f88b7-421d-427e-b03c-fc9c9504a23e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 12, 2016
Package DI Number
20885554035838
Quantity per Package
6
Contains DI Package
00885554035834
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |