Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780415015
• Version / Model: V933-201
• Catalog Number: V933-201
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-22
• Public Version: 4
• Public Version Date: 2023-05-02
• Public Version Status: Update
• Public Device Record Key: 391df94e-f4c6-4c97-9e59-8e24271940b5

Device Description

Integra® Miltex® Schamberg Comedone Extractor, 3-3/4", Small End Crimped

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: 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: 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
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
Secondary	H834V9332010	HIBCC
Primary	10381780415015	GS1

Customer Contacts

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