Coborns/UltiGuard

GUDID 30357515035432

4mm Coborn's UltiGuard Safe Pack Pen Needles

ULTIMED, INC.

Autoinjector needle
Primary Device ID30357515035432
NIH Device Record Key84a73cc2-9423-47df-895c-349ff68b1e4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoborns/UltiGuard
Version Model Number09543CB
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
GS100357515710031 [Unit of Use]
GS120357515035435 [Primary]
GS130357515035432 [Package]
Contains: 20357515035435
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

Devices Manufactured by ULTIMED, INC.

30357515745010 - Simpli2023-05-01 Simpli 4mm UltiGuard
30357515745027 - Simpli2023-05-01 Simpli 5mm Pen Needle UltiGuard
30357515745034 - Simpli2023-05-01 Simpli 6mm Pen Needle UltiGuard
30357515745058 - Simpli2023-05-01 Simpli 8mm Pen Needle UltiGuard
20357515460015 - UltiCare2023-03-09 1mL oral Syringe
20357515460039 - UltiCare2023-03-09 3mL oral syringe
10357515460056 - UltiCare2023-03-09 5mL oral syringe
20357515460107 - UltiCare2023-03-09 10mL oral syringe

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