Duns Number:001292192
Device Description: SYRINGE 1ML ST BULK CONVENIENCE PAK
Catalog Number
309701
Brand Name
N/A
Version/Model Number
309701
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
K110771,K110771,K110771
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
26b0c554-a6d3-45fe-a697-98351b9e8c42
Public Version Date
October 01, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382903097017
Quantity per Package
12
Contains DI Package
30382903097013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |