FDA.reportPublic FDA data

Acu-Dispo-Curette

Primary DI
00814105020005
Brand
Acu-Dispo-Curette
Company
ACUDERM, INC.
Model
R01
Device description
Acu-Dispo-Curette 1mm cup
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K891334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K891334000ACU-CURETTEAcuderm, Inc.1989-04-11FZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814105020002PackageGS125In Commercial Distribution
20814105020009PackageGS150In Commercial Distribution
30814105020006PackageGS1100In Commercial Distribution
00814105020005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081410502000210814105020002
2081410502000920814105020009
3081410502000630814105020006
00814105020005008141050200058141050200050814105020005

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071426803
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020012Acu-Dispo-CuretteR022020-09-22
00814105020029Acu-Dispo-CuretteR032020-09-22
00814105020036Acu-Dispo-CuretteR042020-09-22
00814105020043Acu-Dispo-CuretteR052020-09-22
00814105020050Acu-Dispo-CuretteR072020-09-22
00814105021316Acu-Dispo-CuretteRCOM2020-09-22
00814105021323Acu-Dispo-CuretteRCOMPL2020-09-22
00814105020876ACU-GUARD0ADG51S2020-01-03
10814105020873ACU-GUARDADG51S2020-01-03
10814105021108Acu-ScissorsSCS2020-09-22
10814105021115Acu-ScissorsSCC2020-09-22
10814105021207ACU-DTMM1012020-09-22
10814105021214ACU-DTMM1012020-09-22
10814105021221ACU-SABOURAUDM1032020-09-22
10814105021238ACU-NICKERSONM1042020-09-22
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22
00814105020920Acu-PunchP32020-09-22

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Primary DI, Brand, Company table
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