Unifine Pentips - 5mm x 31G AN0550SB10

GUDID 00384700550011

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384700550011
NIH Device Record Key334db8b4-50b4-4219-b5e2-7b49ca5c57bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 5mm x 31G
Version Model NumberAN0550SB10
Catalog NumberAN0550SB10
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count10
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

Device Dimensions

Needle Gauge31 Gauge
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384700550001 [Unit of Use]
GS100384700550011 [Primary]
GS100384700550035 [Package]
Package: Case [100 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 - 5mm x 31G]

00384703550018For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384703450011For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702050014For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384701150012For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550912For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550813For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550714For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550615For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550516For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550417For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550318For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550219For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550011For use with injectors for the subcutaneous injection of approved drugs, including insulin

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