Comfort EZ Pro 50002-0860-71

GUDID 10850002860716

Safety Insulin Pen Needles - 31G 5mm 100 count

S.D.I. USA, INC.

Hypodermic needle, single-use
Primary Device ID10850002860716
NIH Device Record Key27e7f8b8-8be8-438e-a713-187321eafb57
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort EZ Pro
Version Model NumberSPN-31G5
Catalog Number50002-0860-71
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 Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002860719 [Primary]
GS110850002860716 [Package]
Contains: 00850002860719
Package: Case [12 Units]
In Commercial Distribution
GS120850002860713 [Unit of Use]

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-09
Device Publish Date2023-08-01

On-Brand Devices [Comfort EZ Pro]

10850002860723Safety Insulin Pen Needles - 31G 4mm 100 count
10850002860716Safety Insulin Pen Needles - 31G 5mm 100 count
10850002860709Safety Insulin Pen Needles - 30G 8mm 100 count

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