Duns Number:006999528
Device Description: Kroger Pentips, 5mm x 31G, 100 ct
Catalog Number
-
Brand Name
Kroger
Version/Model Number
AN 3550KRO
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
K152339,K152339,K152339,K152339
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
125696a8-9b48-43a1-88b6-f79d8009bdbc
Public Version Date
June 21, 2021
Public Version Number
1
DI Record Publish Date
June 11, 2021
Package DI Number
20041260007228
Quantity per Package
10
Contains DI Package
00041260007224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sleeve
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 |