Acu-Dispo-Curette

Basic Information

• Brand Name: Acu-Dispo-Curette
• Primary DI: 00814105020029
• Version / Model: R03
• 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: fba4c518-8848-4cbc-b55b-76db134bf027

Device Description

Acu-Dispo-Curette 3mm, 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: No
• 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
FZS	Curette, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63259	Dermal curette	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814105020029	GS1
Package	10814105020026	GS1	Box	25	In Commercial Distribution
Package	20814105020023	GS1	Box	50	In Commercial Distribution
Package	30814105020020	GS1		100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K891334	000