Duns Number:783518983
Device Description: (1/2cc)(5/16")(32G) Single use disposable insulin syringes. Includes 100 sterile needles i (1/2cc)(5/16")(32G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
Catalog Number
7409
Brand Name
Easy Comfort Insulin Syringes (1/2cc)(5/16")(32G)
Version/Model Number
INS0532-0516
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)
-
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
e80aeb93-7345-4683-a384-32e242be53a3
Public Version Date
March 25, 2021
Public Version Number
2
DI Record Publish Date
September 20, 2019
Package DI Number
10850632007406
Quantity per Package
20
Contains DI Package
00850632007409
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |