Python Plate LEFT

GUDID 00853114006037

Anatomic Tension Side Plate

TREACE MEDICAL CONCEPTS, INC.

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile

• Primary Device ID: 00853114006037
• NIH Device Record Key: 078ee079-8576-4f34-bc9f-7f95147ee78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Python Plate LEFT
• Version Model Number: SD11
• 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	00853114006037 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-27

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