Unifine Pentips

GUDID 00761059354024

Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059354024
NIH Device Record Keyc5de42e2-583d-492f-bd38-729dcc0f68e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips
Version Model NumberAN 3540AC
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

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
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
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
GS100038470354002 [Unit of Use]
GS100761059354000 [Primary]
GS100761059354024 [Package]
Contains: 00761059354000
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059354031 [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 Date2024-02-13
Device Publish Date2024-02-05

On-Brand Devices [Unifine Pentips]

00761059352921Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G
00761059354024Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G

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