Pathfinder™ ACL System

GUDID 10850039930062

Flexible Guide Pin with Sheath Adaptor, 5 Guide Pins, 5 Sheaths

Danamed, Inc.

Surgical drill guide, single-use

• Primary Device ID: 10850039930062
• NIH Device Record Key: af6c4a64-eae2-48ff-b44f-68f668dc070f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pathfinder™ ACL System
• Version Model Number: 024GP
• Company DUNS: 080919105
• Company Name: Danamed, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
GS1	10850039930062 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [Pathfinder™ ACL System]

• 00850039930058: Pathfinder ACL Guide, Left Knee, 8 mm offset
• 00850039930041: Pathfinder ACL Guide, Right Knee, 8 mm offset
• 00850039930034: Pathfinder ACL Guide, Left Knee, 7 mm offset
• 00850039930027: Pathfinder ACL Guide, Right Knee, 7 mm offset
• 00850039930010: Pathfinder ACL Guide, Left Knee, 5.5mm offset
• 00850039930003: Pathfinder ACL Guide, Right Knee, 5.5mm offset
• 50850039930060: Flexible Guide Pin with Sheath Adaptor, 1 Guide Pin, 1 Sheath
• 40850039930063: Flexible Guide Pin with Sheath Adaptor, 2 Guide Pins, 2 Sheaths
• 30850039930066: Flexible Guide Pin with Sheath Adaptor, 3 Guide Pins, 3 Sheaths
• 20850039930069: Flexible Guide Pin with Sheath Adaptor, 4 Guide Pins, 4 Sheaths
• 10850039930062: Flexible Guide Pin with Sheath Adaptor, 5 Guide Pins, 5 Sheaths
• 00850039930065: Flexible Guide Pin with Sheath Adaptor, 1 Guide Pin, 1 Sheath