Duns Number:006999528
Device Description: 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
Catalog Number
-
Brand Name
Kroger Insulin Syringes
Version/Model Number
103008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2017
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
K062702,K062702,K062702
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
7282ace5-dfa0-42c6-a742-04a5c7940d6c
Public Version Date
August 05, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10011110353228
Quantity per Package
30
Contains DI Package
00011110353221
Package Discontinue Date
July 17, 2017
Package Status
Not in Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |