FDA.reportPublic FDA data

Acu-Punch

Primary DI
00814105020975
Brand
Acu-Punch
Company
ACUDERM, INC.
Model
P6
Device description
Acu-Punch, 6mm, Single
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00814105021675PackageGS110In Commercial Distribution
10814105020972PackageGS125In Commercial Distribution
20814105020979PackageGS150In Commercial Distribution
00814105020975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814105021675008141050216758141050216750814105021675
1081410502097210814105020972
2081410502097920814105020979
00814105020975008141050209758141050209750814105020975

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.

Regulatory Flags#

DUNS number
071426803
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22
00814105020920Acu-PunchP32020-09-22
00814105020937Acu-PunchP3.52020-09-22
00814105020944Acu-PunchP42020-09-22
00814105020951Acu-PunchP4.52020-09-22
00814105020968Acu-PunchP52020-09-22
00814105020982Acu-PunchP72020-09-22
00814105020999Acu-PunchP82020-09-22
00814105021002Acu-PunchP102020-09-22
00814105021019Acu-PunchP122020-09-22
00814105021316Acu-Dispo-CuretteRCOM2020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060411987579Oral Rotating Biopsy Punch 120 mmDTR MEDICAL LIMITEDEME2026-06-12
05060411987586Oral Biopsy Punch Long 180 mmDTR MEDICAL LIMITEDEME2026-06-12
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05060212051073Oral Biopsy Forceps Long 120mmDTR MEDICAL LIMITEDEME2026-06-11
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