GNP

GUDID 00087701434280

5mm pen needle UltiGuard

AMERISOURCEBERGEN DRUG CORPORATION

Autoinjector needle
Primary Device ID00087701434280
NIH Device Record Key2accf344-37aa-4894-a970-0ea8ee7592c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGNP
Version Model Number09553GNP
Company DUNS007914906
Company NameAMERISOURCEBERGEN DRUG CORPORATION
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
GS100087701434280 [Package]
Contains: 00087701434327
Package: UltiGuard [1 Units]
In Commercial Distribution
GS100087701434327 [Primary]
GS100357515710130 [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 Date2022-02-07
Device Publish Date2022-01-28

On-Brand Devices [GNP ]

000877014343038mm pen needle UltiGuard
000877014342976mm 32G pen needle UltiGuard
000877014342805mm pen needle UltiGuard
003575157100558mm pen needle UltiGuard

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