N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00818613020076
• Version / Model: II-1-0335
• Catalog Number: II-1-0335
• Company Name: Integrity Implants Inc.
• Labeler DUNS: 080300717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-23
• Public Version: 4
• Public Version Date: 2022-05-13
• Public Version Status: Update
• Public Device Record Key: 466430e1-026a-4395-9a39-97ed2ace88dd

Device Description

Cannula Assembly 27mm

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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58753	Arthroscopic obturator	A non-sterile, hand-held manual surgical instrument designed to fill the lumen of an arthroscopic sleeve (not included) to facilitate insertion of the sleeve into a joint (e.g., shoulder, knee) during arthroscopic examination or surgery. It is typically cannulated, made of metal, and available in a variety of sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818613020076	GS1

Customer Contacts

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