TopRx 1st Tier UP

GUDID 00761059590873

TopRx 1st Tier UP Pen needles - 6mm x 32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059590873
NIH Device Record Keya3bccf97-2da9-43a5-a042-7ee9f686c0a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopRx 1st Tier UP
Version Model NumberAN 3595TRX
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

Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge
Length6 Millimeter
Needle Gauge32 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703595002 [Unit of Use]
GS100761059590873 [Package]
Contains: 00761059595878
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059591870 [Package]
Package: Case [5 Units]
In Commercial Distribution
GS100761059595878 [Primary]

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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