Pentips 1st Tier

GUDID 00761059429029

Pentips 1st Tier pen needles Original, 12mm x 29G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059429029
NIH Device Record Keyee143a78-2ff1-48dc-9c58-aba0ce3400b4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePentips 1st Tier
Version Model NumberAN 3429FT
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 Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703429000 [Unit of Use]
GS100761059429012 [Primary]
GS100761059429029 [Package]
Contains: 00761059429012
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059429036 [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 Date2023-07-03
Device Publish Date2023-06-23

On-Brand Devices [Pentips 1st Tier]

00761059490029Pentips 1st Tier pen needles, 6mm x 31G
00761059450023Pentips 1st Tier pen needles Mini, 5mm x 31G
00761059440024Pentips 1st tier pen needles, 4mm x 32G
00761059430025Pentips 1st Tier pen needles Short, 8mm x 31G
00761059429029Pentips 1st Tier pen needles Original, 12mm x 29G

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