Innomed, Inc.

Basic Information

• Brand Name: Innomed, Inc.
• Primary DI: 00840277120403
• Version / Model: AR-8948CD
• Catalog Number: AR-8948CD
• Company Name: INNOMED, INC.
• Labeler DUNS: 878427491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-27
• Public Version: 1
• Public Version Date: 2022-05-05
• Public Version Status: New
• Public Device Record Key: 29f3f76a-17f1-441f-8550-0c2c8b1cf996

Device Description

Calcaneal Distractor Small Straight

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
62787	Orthopaedic surgical distractor, external	A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840277120403	GS1