Unifine Pentips - 4mm x 33G AN0560SB6

GUDID 00384700560614

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle
Primary Device ID00384700560614
NIH Device Record Key6eaff6ec-635d-4e66-9383-1e267207f8d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 4mm x 33G
Version Model NumberAN0560SB6
Catalog NumberAN0560SB6
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count6
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

Device Dimensions

Needle Gauge33 Gauge
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384700560004 [Unit of Use]
GS100384700560614 [Primary]
GS100384700560638 [Package]
Package: Case [100 Units]
In Commercial Distribution
GS100384703560000 [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 - 4mm x 33G]

00384700560911For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560812For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560713For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560614For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560515For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560416For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560317For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560232For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700560010For use with injectors for the subcutaneous injection of approved drugs, including insulin

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