Unifine Pentips

GUDID 00761059352921

Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059352921
NIH Device Record Keyc9fa3bdc-d88e-40ad-a5f9-741d92f30021
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips
Version Model NumberAN 3529AC
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

Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter
Needle Gauge29 Gauge
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703529007 [Unit of Use]
GS100761059352914 [Primary]
GS100761059352921 [Package]
Contains: 00761059352914
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059352938 [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 Date2024-01-30
Device Publish Date2024-01-22

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

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