Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 40649111016937
• Version / Model: 21-171
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-07-11
• Public Version: 1
• Public Version Date: 2018-08-13
• Public Version Status: New
• Public Device Record Key: a0422000-b187-4e40-944d-5e7936d6bd25

Device Description

BUCK EAR CURETTE BL STR#0 BX12

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
62588	Deep skin exfoliant	A substance intended to be applied to the skin, left in place for a few minutes or hours and then peeled away, resulting in the removal of all the epidermis and some portion of the dermis. It typically contains acids (e.g., trichloroacetic acid, phenol) and may require several treatment sessions. It is used by a healthcare professional for the removal of abnormal lesions (e.g., actinic or seborrheic keratosis, pre-malignant lesions), acne scars, pigmentation disorders, or for cosmetic purposes. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	40649111016937	GS1
Unit of Use	00649111016939	GS1