Duns Number:109903521
Device Description: DYONICS PIN PROTECTOR 1/8 LAVENDER
Catalog Number
72204503
Brand Name
DYONICS
Version/Model Number
72204503
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863734,K863734,K863734
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
466f1903-a7c8-420d-883c-f46a011721ed
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 07, 2017
Package DI Number
30885554035958
Quantity per Package
6
Contains DI Package
20885554035951
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 |