Duns Number:025460908
Device Description: DBD-SYR W/NDLE,HYPODERM,LL,22GX1.25", 3M
Catalog Number
SYR103226
Brand Name
Medline
Version/Model Number
SYR103226
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"
Yes
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
39fe2202-8d3a-4d03-a2b6-d346983b51e3
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
Package DI Number
30080196449549
Quantity per Package
100
Contains DI Package
10080196449545
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |