Unifine Pentips Plus - 8mm x 31G AN0830SB6

GUDID 00384700830618

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384700830618
NIH Device Record Keyeff38a4b-7a7d-4b32-8a46-3339d0bd2fcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips Plus - 8mm x 31G
Version Model NumberAN0830SB6
Catalog NumberAN0830SB6
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count6
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
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
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Needle Gauge31 Gauge
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 Millimeter
Needle Gauge31 Gauge
Length8 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
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
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
GS100384700830008 [Unit of Use]
GS100384700830618 [Primary]
GS100384700830632 [Package]
Package: Case [100 Units]
In Commercial Distribution
GS100384703830004 [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 - 8mm x 31G]

00384703830035For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702830036For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830915For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830816For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830717For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830618For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830519For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830410For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830311For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830212For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700830038For use with injectors for the subcutaneous injection of approved drugs, including insulin

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