Unifine Pentips Plus - 12mm x 29G AN2829

GUDID 00384702829030

For use with injectors for the subcutaneous injection of approved drugs, including insulin

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384702829030
NIH Device Record Keyc1f416ff-558b-4838-88f1-d4515fa5df88
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips Plus - 12mm x 29G
Version Model NumberAN2829
Catalog NumberAN2829
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count90
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
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Length12 Millimeter
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384702829006 [Unit of Use]
GS100384702829016 [Primary]
GS100384702829023 [Package]
Contains: 00384702829016
Package: Sleeve [6 Units]
In Commercial Distribution
GS100384702829030 [Package]
Contains: 00384702829023
Package: Case [24 Units]
In Commercial Distribution
GS100384703829008 [Unit of Use]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Unifine Pentips Plus - 12mm x 29G]

00384703829039For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702829030For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829919For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829810For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829711For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829612For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829513For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829414For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829315For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829216For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700829018For use with injectors for the subcutaneous injection of approved drugs, including insulin

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