Unifine Pentips - 12mm x 29G AN0529SB7

GUDID 00384700529710

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384700529710
NIH Device Record Key2f4247a7-f885-4992-99aa-2b3b0dc0be33
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 12mm x 29G
Version Model NumberAN0529SB7
Catalog NumberAN0529SB7
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count7
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 Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

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

Device Dimensions

Needle Gauge29 Gauge
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
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
GS100384700529000 [Unit of Use]
GS100384700529710 [Primary]
GS100384700529734 [Package]
Package: Case [100 Units]
In Commercial Distribution
GS100384703529007 [Unit of Use]

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 - 12mm x 29G]

00384703529038For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384703429031For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702029010For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529918For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529819For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529710For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529611For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529512For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529437For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529314For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529215For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700529017For use with injectors for the subcutaneous injection of approved drugs, including insulin

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