1st Choice, AMMEX Professional

GUDID 10819856020394

AMMEX CORPORATION

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10819856020394
NIH Device Record Keye77f56f0-35d7-4fb8-af9e-08110bf0cbb9
Commercial Distribution StatusIn Commercial Distribution
Brand Name1st Choice, AMMEX Professional
Version Model Number1EBNVPFLCS2
Company DUNS187070768
Company NameAMMEX CORPORATION
Device Count1
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
GS110819856020394 [Primary]

FDA Product Code

LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

Devices Manufactured by AMMEX CORPORATION

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10697383978490 - AMMEX Professional2024-10-29 Sample Box
10697383978506 - Gloveworks2024-10-29 Sample Box
10697383978513 - AMMEX Professional2024-10-29 Sample Box
10697383978520 - AMMEX Professional2024-10-29 Sample Box
20697383978480 - AMMEX Professional2024-10-29 Sample Case
20697383978497 - AMMEX Professional2024-10-29 Sample Case
20697383978503 - Gloveworks2024-10-29 Sample Case

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