Compressor & Distractor

Basic Information

• Brand Name: Compressor & Distractor
• Primary DI: 00853114006969
• Version / Model: 1405-2427
• Company Name: Treace Medical Concepts, Inc.
• Labeler DUNS: 054808082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-12
• Public Version: 2
• Public Version Date: 2022-11-16
• Public Version Status: Update
• Public Device Record Key: ac40ba36-0f7d-4a61-adef-1d1489f70af8

Device Description

compressor

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
HWN	Instrument, Compression	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	00853114006969	GS1