Duns Number:556115970
Device Description: SYRINGE,1CC 27 X 1/2,LUER SLIP,TB
Catalog Number
-
Brand Name
AHS
Version/Model Number
AH01T2713
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
c00c1886-92b9-4827-8f81-27cd6eda3b19
Public Version Date
November 09, 2020
Public Version Number
5
DI Record Publish Date
March 31, 2016
Package DI Number
B031AH01T27132
Quantity per Package
3200
Contains DI Package
B031AH01T27131
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |