Acu-Punch

Basic Information

• Brand Name: Acu-Punch
• Primary DI: 00814105020975
• Version / Model: P6
• Company Name: ACUDERM, INC.
• Labeler DUNS: 071426803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: c8a47bd9-ceb4-4d31-9a19-b8f5c68b63d7

Device Description

Acu-Punch, 6mm, Single

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EME	Punch, Biopsy, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63166	Skin-coring punch, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814105020975	GS1
Package	10814105020972	GS1	Box	25	In Commercial Distribution
Package	20814105020979	GS1	Box	50	In Commercial Distribution