CrossFix®

GUDID M543CM8001

CrossFix® All-Suture Meniscal Repair, straight

CAYENNE MEDICAL, INC.

Polyolefin suture, multifilament

• Primary Device ID: M543CM8001
• NIH Device Record Key: 538d3687-8965-4640-ad6a-6c7f6e2c4b82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossFix®
• Version Model Number: CM-8001
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	M543CM8001 [Primary]

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-23

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