iFix® CM-1345

GUDID M543CM1345

CAYENNE MEDICAL, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M543CM1345
• NIH Device Record Key: 3f841daa-5e86-4c45-b7ef-1c9b60ccab92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFix®
• Version Model Number: CM-1345
• Catalog Number: CM-1345
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	M543CM1345 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M543CM1345]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-03-29

On-Brand Devices [iFix®]

• M543CM7120: CM-7120
• M543CM1612: CM-1612
• M543CM1345: CM-1345
• M543CM1245: CM-1245
• 00887868269608: iFix™ Interference Screw - 9mm x 30mm
• 00887868269592: iFix™ Interference Screw - 9mm x 25mm
• 00887868269585: iFix™ Interference Screw - 9mm x 20mm
• 00887868269578: iFix™ Interference Screw - 8mm x 30mm
• 00887868269561: iFix™ Interference Screw - 8mm x 25mm
• 00887868269554: iFix™ Interference Screw - 8mm x 20mm
• 00887868269547: iFix™ Interference Screw - 7mm x 25mm
• 00887868269530: iFix™ Interference Screw - 7mm x 20mm
• 00887868269516: CM-1345
• 00887868269509: CM-1245
• 00887868269493: iFix™ Interference Screw - 12mm x 30mm
• 00887868269486: iFix™ Interference Screw - 11mm x 30mm
• 00887868269479: iFix™ Interference Screw - 10mm x 30mm
• 00887868269462: iFix™ Interference Screw - 10mm x 25mm