ACU-NICKERSON

GUDID 00814105021231

ACU-NICKERSON, 24/Bx

ACUDERM, INC.

Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD Candida albicans microbial identification reagent IVD
Primary Device ID00814105021231
NIH Device Record Key6170a8ff-a34a-445c-9479-28769a4fc8b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameACU-NICKERSON
Version Model NumberM104
Company DUNS071426803
Company NameACUDERM, INC.
Device Count24
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814105021231 [Unit of Use]
GS110814105021238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSJCulture Media, Selective And Non-Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-30
Device Publish Date2020-09-22

Devices Manufactured by ACUDERM, INC.

00814105020005 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 1mm cup
00814105020012 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 2mm, Single
00814105020029 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 3mm, Single
00814105020036 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 4mm, Single
00814105020043 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 5mm, Single
00814105020050 - Acu-Dispo-Curette2020-09-30 Acu-Dispo-Curette 7mm, Single
00814105020883 - Acu-Punch2020-09-30 Acu-Punch, 1mm, 1ea
00814105020890 - Acu-Punch2020-09-30 Acu-Punch, 1.5mm, Single

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