Fred's Unifine Pentips Plus - Short 8mmx31G AN 3830FRD

GUDID 00761059307570

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

FRED'S, INC.

Autoinjector needle
Primary Device ID00761059307570
NIH Device Record Keyaa23154a-3231-4967-80fa-c78e1e7d7f14
Commercial Distribution StatusIn Commercial Distribution
Brand NameFred's Unifine Pentips Plus - Short 8mmx31G
Version Model NumberAN 3830FRD
Catalog NumberAN 3830FRD
Company DUNS005866116
Company NameFRED'S, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-374-7417
Emailxx@xx.xx
Phone800-374-7417
Emailxx@xx.xx

Device Dimensions

Length8 Millimeter
Length8 Millimeter
Length8 Millimeter
Length8 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703850009 [Unit of Use]
GS100761059307570 [Primary]
GS100761059831570 [Package]
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059832577 [Package]
Contains: 00761059831570
Package: Case [24 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19