Coborn's/UltiGuard

GUDID 30357515035739

8mm Coborn's UltiGuard Safe Pack Pen Needles

ULTIMED, INC.

Autoinjector needle
Primary Device ID30357515035739
NIH Device Record Keyaf6fa694-e7dd-420d-9e17-86778a454258
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoborn's/UltiGuard
Version Model Number09583CB
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]
GS120357515035732 [Primary]
GS130357515035739 [Package]
Contains: 20357515035732
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 Date2019-10-28
Device Publish Date2019-10-18