TopRx 1st Tier UP

GUDID 00761059551874

TopRx 1st Tier UP Pentips - 5mm x 31G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059551874
NIH Device Record Key019c03d9-590f-48a5-a738-73e28c19eac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopRx 1st Tier UP
Version Model NumberAN 3550TRX
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
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com

Device Dimensions

Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703550001 [Unit of Use]
GS100761059550877 [Primary]
GS100761059551874 [Package]
Contains: 00761059550877
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059552871 [Package]
Package: Case [5 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 Date2022-06-10
Device Publish Date2022-06-02

On-Brand Devices [TopRx 1st Tier UP]

00761059590873TopRx 1st Tier UP Pen needles - 6mm x 32G
00761059551874TopRx 1st Tier UP Pentips - 5mm x 31G
00384703540002TopRx 1st Tier UP Pentips - 4mmx32G
00761059531876TopRx 1st Tier UP pen needles - 6mm x 32G
00761059420873TopRx 1st Tier Pentips pen needles -12mm x 29G

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