Duns Number:007924756
Device Description: 1mL 31G 5/16 (8mm) Single use insulin syringe with needle. Includes 100 sterile syringes.
Catalog Number
79146
Brand Name
HEB In-Control Insulin Syringe
Version/Model Number
79146
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"
-
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
K152879,K152879
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
bc8c2b3a-bb94-41be-8281-cebc1ff5dc13
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |