Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780083146
• Version / Model: 3724064
• Catalog Number: 3724064
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 3
• Public Version Date: 2023-04-17
• Public Version Status: Update
• Public Device Record Key: 49a95033-fb8b-4e7d-b67c-d64d360aae9a

Device Description

Integra® House Cutting Block, Autoclavable

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: Yes
• 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
NNR	BLOCK, CUTTING, ENT, NON-STERILE	Ear, Nose, Throat	874.3540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16859	Dissection board	A flat, stiff device on which an object (a human or animal body or body part) is placed for support during dissection procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780083146	GS1

Customer Contacts

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