Duns Number:117970217
Catalog Number
-
Brand Name
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
Version/Model Number
SYR-P-05
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)
-
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
044b15f5-a3d0-430b-ab79-cb19fd5057d1
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
Package DI Number
10810080610573
Quantity per Package
20
Contains DI Package
00810080610576
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 | 103 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |