Duns Number:825097264
Device Description: 1mL 28G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syr 1mL 28G 12.7mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags.
Catalog Number
22-8010
Brand Name
Sure Comfort
Version/Model Number
22-8010
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
43fab361-4da2-4a30-a75d-d7359d7a3f92
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 03, 2016
Package DI Number
00786227801094
Quantity per Package
6
Contains DI Package
00786227801056
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |