Unifine Pentips - 6mm x 31G AN3490

GUDID 00384703490017

For use with injectors for the subcutaneous injection of approved drugs, including insulin

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384703490017
NIH Device Record Keye7d257b6-3945-4aac-af40-11223e2ef5f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 6mm x 31G
Version Model NumberAN3490
Catalog NumberAN3490
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Length6 Millimeter
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703490007 [Unit of Use]
GS100384703490017 [Primary]
GS100384703490024 [Package]
Package: Sleeve [10 Units]
In Commercial Distribution
GS100384703490031 [Package]
Contains: 00384703490024
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Unifine Pentips - 6mm x 31G]

00384703590014For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384703490017For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702090010For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384701190018For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590918For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590819For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590734For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590611For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590512For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590413For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590314For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590215For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700590031For use with injectors for the subcutaneous injection of approved drugs, including insulin

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