Snap-Off Screw System

GUDID 00853114006143

2.0mm Snap-Off Screw System

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00853114006143
• NIH Device Record Key: ca6cd507-0555-4880-88c6-6d7fd3113c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Snap-Off Screw System
• Version Model Number: SK21
• Company DUNS: 054808082
• Company Name: TREACE MEDICAL CONCEPTS, 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: 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
GS1	00853114006143 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2019-07-02
• Device Publish Date: 2019-06-24

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