Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780479185
• Version / Model: 22-900
• Catalog Number: 22-900
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-16
• Public Version: 3
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: c5b5f85a-2fd3-4606-9fc7-06b1d5071533

Device Description

Integra® Miltex® Lewis Tonsil Screw, 8", Two Sharp Points, Standard Small Size

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
KBX	SCREW, TONSIL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14070	Tonsillectome	A hand-held manual surgical instrument designed to remove tonsils during a toncillectomy. It can be designed as either a flexible loop for grasping and holding the tonsil or a metal frame which holds and guides a sliding knife blade (a guillotine). The loop type holds the tonsil so it may be surgically cut with a knife. The frame type has a variety of designs of manual cranks that operate the sliding knife blade which cuts off the tonsil. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834229000	HIBCC
Primary	10381780479185	GS1

Customer Contacts

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