Comedone Extractor

Basic Information

• Brand Name: Comedone Extractor
• Primary DI: 00192896118171
• Version / Model: 199-160T
• Catalog Number: 199-160T
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-21
• Public Version: 1
• Public Version Date: 2024-07-01
• Public Version Status: New
• Public Device Record Key: 37454824-5ff8-480b-b824-3027caa32d6e

Device Description

Comedone Extractor Double End Fenestrated Curved Cup/Straight Lancet Titanium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57817	Comedo expressor	A manual instrument designed for pressing or squeezing out a comedo (black head) from the mouth of sebaceous follicles. It typically consists of a hand-held device with one or both ends appropriately configured (e.g., crimped, spoon-like, forming loops) for the extraction of plugging comedos. The instrument is used in the treatment of acne; it may be used also for plantar warts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896118171	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	5.75	Inch