Unifine Pentips Plus - 6mm x 31G AN0890SB10

GUDID 00384700890032

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384700890032
NIH Device Record Key61da585c-70e9-4d02-8b45-78bc1aaf643c
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips Plus - 6mm x 31G
Version Model NumberAN0890SB10
Catalog NumberAN0890SB10
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count10
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

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

Needle Gauge31 Gauge
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge
Length6 Millimeter
Needle Gauge31 Gauge

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
GS100384700890008 [Unit of Use]
GS100384700890018 [Primary]
GS100384700890032 [Package]
Contains: 00384700890018
Package: Case [100 Units]
In Commercial Distribution
GS100384703890008 [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 - 6mm x 31G]

00384703890039For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702890016For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890919For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890810For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890711For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890612For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890513For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890414For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890315For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890216For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700890032For use with injectors for the subcutaneous injection of approved drugs, including insulin

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