CrossFix® CM-8000

GUDID M543CM8000

CAYENNE MEDICAL, INC.

Arthroscopic surgical procedure kit, non-medicated, single-use

• Primary Device ID: M543CM8000
• NIH Device Record Key: 90151014-92f1-4ffd-a17d-ea3d08649712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossFix®
• Version Model Number: CM-8000
• Catalog Number: CM-8000
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M543CM8000 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29

On-Brand Devices [CrossFix®]

• M543CM9300: CM-9300
• M543CM8000: CM-8000
• 00887868270031: CM-8000
• M543CM8002: CrossFix® All-Suture Meniscal Repair, curved
• M543CM8001: CrossFix® All-Suture Meniscal Repair, straight