Unifine Pentips - 4mm x 33G AN3560

GUDID 00384703560017

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384703560017
NIH Device Record Key08043917-a22b-48b7-995d-c0d4fb2b0bea
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 4mm x 33G
Version Model NumberAN3560
Catalog NumberAN3560
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
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

Length4 Millimeter
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 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
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
GS100384703560000 [Unit of Use]
GS100384703560017 [Primary]
GS100384703560024 [Package]
Package: Sleeve [10 Units]
In Commercial Distribution
GS100384703560031 [Package]
Contains: 00384703560024
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-05
Device Publish Date2018-10-03

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