Duns Number:065762392
Device Description: Disposable 1/2CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag
Catalog Number
GE12007
Brand Name
Biotronix Healthcare Syringes
Version/Model Number
GE12007
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
K110421,K110421,K110421
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
ef139960-325c-4e32-9877-597498d8184b
Public Version Date
December 24, 2019
Public Version Number
3
DI Record Publish Date
October 12, 2019
Package DI Number
20858835007367
Quantity per Package
10
Contains DI Package
10858835007360
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 |