Disposa-Derm® Skin Biopsy Punches Sample Set

Basic Information

• Brand Name: Disposa-Derm® Skin Biopsy Punches Sample Set
• Primary DI: 60888937016699
• Version / Model: 5-PC
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-15
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 12a216d1-9929-4c35-a668-38f9bad8480a

Device Description

Disposa-Derm® Skin Biopsy Punches Sample Set 1 each: 2 mm, 3 mm, 4 mm, 5 mm, 6 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
35286	Biopsy punch, reusable	A manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	60888937016699	GS1