TopRx 1st Tier Pentips

GUDID 00761059441878

TopRx 1st Tier Pentips pen needles - 4mm x 32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059441878
NIH Device Record Key5a35c192-5741-4e92-b8cc-a054e8e3692c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopRx 1st Tier Pentips
Version Model NumberAN 3440TRX
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

Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703440005 [Unit of Use]
GS100761059440871 [Primary]
GS100761059441878 [Package]
Contains: 00761059440871
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059442875 [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 Pentips]

00761059491873TopRx 1st Tier Pentips pen needles - 6mm x 31G
00761059451877TopRx 1st Tier Pentips pen needles - 5mm x 31G
00761059441878TopRx 1st Tier Pentips pen needles - 4mm x 32G
00761059431879TopRx 1st Tier Pentips pen needles - 8mm x 31G

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.