Comfort EZ 50002-0860-06

GUDID 00850002860061

Insulin Pen Needle

S.D.I. USA, INC.

Autoinjector needle
Primary Device ID00850002860061
NIH Device Record Keyfec1338d-5b21-4330-875d-121ba0d2c0af
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort EZ
Version Model Number32G5
Catalog Number50002-0860-06
Company DUNS116722847
Company NameS.D.I. USA, 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 Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Needle Gauge32 Gauge
Needle Gauge32 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002860061 [Primary]
GS120850002860065 [Unit of Use]

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 Number2
Public Version Date2019-01-25
Device Publish Date2018-10-26

On-Brand Devices [Comfort EZ]

00850002860214Insulin Syringe - 100 count
00850002860207Insulin Syringe - 100 count
00850002860191Insulin Syringe - 100 count
00850002860184Insulin Syringe - 100 count
00850002860177Insulin Syringe - 100 count
00850002860160Insulin Syringe - 100 count
00850002860153Insulin Syringe - 100 count
00850002860146Insulin Syringe - 100 count
00850002860139Insulin Syringe - 100 count
00850002860122Insulin Syringe - 100 count
00850002860115Insulin Pen Needle
00850002860108Insulin Pen Needle
00850002860092Insulin Pen Needle
00850002860085Insulin Pen Needle
00850002860078Insulin Pen Needle
00850002860061Insulin Pen Needle
00850002860054Insulin Pen Needle
00850002860047Insulin Pen Needle
00850002860030Insulin Pen Needle
00850002860023Insulin Pen Needle

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