Comfort EZ Pro 50002-0860-70

GUDID 10850002860709

Safety Insulin Pen Needles - 30G 8mm 100 count

S.D.I. USA, INC.

Hypodermic needle, single-use
Primary Device ID10850002860709
NIH Device Record Key85144c86-c743-4f0c-818b-5c70ff81b46f
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfort EZ Pro
Version Model NumberSPN-30G8
Catalog Number50002-0860-70
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 Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter
Needle Gauge30 Gauge
Length8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002860702 [Primary]
GS110850002860709 [Package]
Contains: 00850002860702
Package: [12 Units]
In Commercial Distribution
GS120850002860706 [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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