Duns Number:825097264
Device Description: 0.5mL 28G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile s 0.5mL 28G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags.
Catalog Number
22-8005
Brand Name
Sure Comfort
Version/Model Number
22-8005
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152879,K152879,K152879,K152879
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
07e20f3f-2bf9-4762-8723-1bd94f21185f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 03, 2016
Package DI Number
00786227800592
Quantity per Package
6
Contains DI Package
00786227800578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |