Duns Number:527035248
Device Description: The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices f The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Catalog Number
-
Brand Name
TKMD
Version/Model Number
TKHM
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
9ec126af-8e63-42a3-8103-d3d6d023cc28
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 28, 2021
Package DI Number
16934841580753
Quantity per Package
100
Contains DI Package
06934841580756
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |