FDA.reportPublic FDA data

Acu-Punch

Primary DI
00814105020913
Brand
Acu-Punch
Company
ACUDERM, INC.
Model
P2.5
Device description
Acu-Punch, 2.5mm, Single
Published
2020-09-22
Public version status
New
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
EMEPunch, Biopsy, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814105020910PackageGS125In Commercial Distribution
20814105020917PackageGS150In Commercial Distribution
00814105020913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081410502091010814105020910
2081410502091720814105020917
00814105020913008141050209138141050209130814105020913

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, single-useA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically made of high-grade stainless steel and is available in various cutting head sizes; it is not a biopsy gun. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071426803
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020005Acu-Dispo-CuretteR012020-09-22
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
00814105020920Acu-PunchP32020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10649111087431Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111225369Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226281Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226458Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226762Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111226984Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111227370Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111228056Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111228919Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111229817Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111230585Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111487415Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111487422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-12
10649111231421Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233159Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233500Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111233784Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111234101Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111231422Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233150Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233501Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111234102Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
10649111082726Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234378Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111234675Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111235078Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111236594Sklar InstrumentsSKLAR CORPORATIONEME2025-11-07
10649111072949Sklar InstrumentsSKLAR CORPORATIONEME2025-11-06
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28