Innomed, Inc.

Basic Information

• Brand Name: Innomed, Inc.
• Primary DI: 00840277114440
• Version / Model: 8031-01
• Catalog Number: 8031-01
• Company Name: INNOMED, INC.
• Labeler DUNS: 878427491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-31
• Public Version: 2
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: c17d46c3-23f1-4a9e-aa9d-41f7db01ad95

Device Description

Debris Shield without Reamer Slot without Case

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
60942	Orthopaedic surgery tissue debris collector, reusable	A device intended to be fitted to an orthopaedic rotary cutting tool (e.g., reamer) to collect bone, cartilage, or adjacent soft tissue debris/fragments created through resection during orthopaedic surgery (e.g., hip resurfacing). It is typically in the form of a cup-shaped attachment intended to prevent particulate bone entering the surgical wound. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840277114440	GS1