Unifine Pentips - 8mm x 31G AN3430

GUDID 00384703430013

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
Primary Device ID00384703430013
NIH Device Record Keyd53ca855-e3f2-4ea9-b29e-d9169548c978
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 8mm x 31G
Version Model NumberAN3430
Catalog NumberAN3430
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

Device Dimensions

Length8 Millimeter
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703430003 [Unit of Use]
GS100384703430006 [Unit of Use]
GS100384703430013 [Primary]
GS100384703430020 [Package]
Package: Sleeve [10 Units]
In Commercial Distribution
GS100384703430037 [Package]
Contains: 00384703430020
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 - 8mm x 31G]

00384703530010For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384703430013For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702030016For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384701130014For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530914For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530815For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530716For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530617For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530518For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530419For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530310For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530211For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700530013For use with injectors for the subcutaneous injection of approved drugs, including insulin

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