Duns Number:065762392
Device Description: Disposable 1CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16"
Catalog Number
-
Brand Name
Biotronix Healthcare Syringes
Version/Model Number
GE12004-R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 31, 2030
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)
Yes
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
0a9a2c53-e8ab-4d25-b4ae-900ba0472e0d
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
September 29, 2019
Package DI Number
00858835007417
Quantity per Package
10
Contains DI Package
00858835007400
Package Discontinue Date
August 31, 2028
Package Status
In Commercial Distribution
Package Type
inner box
| 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 |