Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780424543
• Version / Model: 22-1002
• Catalog Number: 22-1002
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-10
• Public Version: 5
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: 88e75b8e-3ad5-4ad0-b7c7-1231adc5b5e3

Device Description

Integra® Miltex® Eve Tonsil Snare 11-1/4", with Ratchet

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
KBZ	SNARE, TONSIL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13632	Tonsil snare	A manual surgical instrument inserted into the oral cavity to remove the tonsils during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the root of the tonsil to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8342210020	HIBCC
Primary	10381780424543	GS1

Customer Contacts

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