Fred's Unifine Pentips Plus - Micro 4mmx32G AN 3840FRD

GUDID 00761059842576

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

FRED'S, INC.

Autoinjector needle
Primary Device ID00761059842576
NIH Device Record Keycc95424e-0d26-4d0a-a605-746b1888d991
Commercial Distribution StatusIn Commercial Distribution
Brand NameFred's Unifine Pentips Plus - Micro 4mmx32G
Version Model NumberAN 3840FRD
Catalog NumberAN 3840FRD
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

Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 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
GS100384703840000 [Unit of Use]
GS100761059407577 [Primary]
GS100761059841579 [Package]
Contains: 00761059407577
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059842576 [Package]
Contains: 00761059841579
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