TopCare Clickfine Pen Needles

GUDID 10036800250922

Sterile, single-use, 6-bevel pen needles, 31 Gauge, 6mm (1/4") Length

Topco Associates, LLC

Autoinjector needle
Primary Device ID10036800250922
NIH Device Record Key5a7278fa-99c1-40cc-b11d-aa65e6e19ccf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopCare Clickfine Pen Needles
Version Model Number700001339
Company DUNS072943876
Company NameTopco Associates, LLC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100036800250925 [Primary]
GS110036800250922 [Package]
Contains: 00036800250925
Package: Shipper [20 Units]
In Commercial Distribution
GS120036800250929 [Unit of Use]

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-09-18
Device Publish Date2016-09-24

On-Brand Devices [TopCare Clickfine Pen Needles]

10036800250922Sterile, single-use, 6-bevel pen needles, 31 Gauge, 6mm (1/4") Length
10036800250915Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.