Unifine Pentips Plus - 4mm x 33G AN0860SB2

GUDID 00384700860233

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384700860233
NIH Device Record Keyb535e228-bdd7-4cb3-9626-9833220d9ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips Plus - 4mm x 33G
Version Model NumberAN0860SB2
Catalog NumberAN0860SB2
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count2
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 Gauge33 Gauge
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 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
GS100384700860009 [Unit of Use]
GS100384700860219 [Primary]
GS100384700860233 [Package]
Contains: 00384700860219
Package: Case [100 Units]
In Commercial Distribution
GS100384703860001 [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 Date2016-09-21

On-Brand Devices [Unifine Pentips Plus - 4mm x 33G]

00384703860032For use with injectors for the subcutaneous injection of approved drugs, including insulin.
00384700860912For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860813For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860714For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860639For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860516For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860417For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860318For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860233For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700860011For use with injectors for the subcutaneous injection of approved drugs, including insulin

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