YouRx/UltiCare

GUDID 30357515025839

8mm Pen Needle UltiGuard

ULTIMED, INC.

Autoinjector needle
Primary Device ID30357515025839
NIH Device Record Key7419fb7a-f56d-4a15-ab09-7528c3ec067e
Commercial Distribution StatusIn Commercial Distribution
Brand NameYouRx/UltiCare
Version Model Number09583YRX
Company DUNS024723541
Company NameULTIMED, 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100357515710055 [Unit of Use]
GS120357515025832 [Primary]
GS130357515025839 [Package]
Contains: 20357515025832
Package: [12 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-22
Device Publish Date2018-10-22

On-Brand Devices [YouRx/UltiCare]

303575150258398mm Pen Needle UltiGuard
303575150256316mm Pen Needle UltiGuard
303575150254334mm YouRx Pen Needle UltiGuard

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