Duns Number:803401454
Device Description: TopRx 1st Tier Pentips pen needles - 4mm x 32G
Catalog Number
-
Brand Name
TopRx 1st Tier Pentips
Version/Model Number
AN 3440TRX
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)
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
5a35c192-5741-4e92-b8cc-a054e8e3692c
Public Version Date
June 10, 2022
Public Version Number
1
DI Record Publish Date
June 02, 2022
Package DI Number
00761059441878
Quantity per Package
10
Contains DI Package
00761059440871
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 |