Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780075042
• Version / Model: 1458276
• Catalog Number: 1458276
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-04-16
• Public Version: 6
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: 39adf9b7-71b7-45c0-8f77-99f71a1fb6cf

Device Description

Integra® BLADE 1458276 5PK MYRINGOTOMY SPEAR

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYP	KNIFE, MYRINGOTOMY	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63660	Tympanotomy knife, single-use	A hand-held, manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780075042	GS1
Unit of Use	00381780075045	GS1

Customer Contacts

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