Duns Number:803401454
Device Description: Hartig Drug 1st Tier Unifine Pentips pen needles - 4mm x 32G
Catalog Number
-
Brand Name
1st Tier Hartig Drug Unifine Pentips
Version/Model Number
AN 3540HAR
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
K152339,K152339,K152339,K152339
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
5e25036e-dbf9-4feb-b20d-e077075fa1d5
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 16, 2022
Package DI Number
00761059541882
Quantity per Package
10
Contains DI Package
00761059540885
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |