DROPLET 02022987000100

GUDID 50812383030605

PEN NEEDLE 30GX8MM

PIKDARESOCIETA' PER AZIONI

Autoinjector needle
Primary Device ID50812383030605
NIH Device Record Key6745edbc-22d4-49f3-a041-630fd1d2291c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDROPLET
Version Model Number02022987000100
Catalog Number02022987000100
Company DUNS437816603
Company NamePIKDARESOCIETA' PER AZIONI
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-Counterfalse

Customer Support Contacts

Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM
Phone1-866-633-7527
EmailCLAIM@PIKDARE.COM

Device Dimensions

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Device Size Text, specify0
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Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812383030600 [Primary]
GS150812383030605 [Package]
Contains: 00812383030600
Package: CARTON BOX [12 Units]
In Commercial Distribution
GS190812383030603 [Unit of Use]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-29
Device Publish Date2019-07-19