Duns Number:065762392
Device Description: Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
Catalog Number
GE12085
Brand Name
Biotronix Healthcare Syringes
Version/Model Number
GE12085
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
2df46cb8-994a-4d30-9fba-ffb2f0e51038
Public Version Date
October 17, 2022
Public Version Number
4
DI Record Publish Date
October 13, 2019
Package DI Number
20864085000409
Quantity per Package
8
Contains DI Package
10864085000402
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |