EXPERT - Joint Fixation System 314-2000

GUDID 07899258642536

EXPERT Knotless Dual Round Plate Ø6.5mm (2un) Rectangular Plate 3.5x13mm (2un) Support Plate for Syndesmosis 10mm x 40mm (1un)

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 07899258642536
• NIH Device Record Key: 44053e5d-2217-4268-b68f-3eb0ef84ec2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERT - Joint Fixation System
• Version Model Number: EXPERT Knotless Dual
• Catalog Number: 314-2000
• Company DUNS: 900865213
• Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA
• 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
GS1	07899258642536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200332

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2024-01-19
• Device Publish Date: 2024-01-11

On-Brand Devices [EXPERT - Joint Fixation System]

• 07899258642536: EXPERT Knotless Dual Round Plate Ø6.5mm (2un) Rectangular Plate 3.5x13mm (2un) Support Plate fo
• 07899258638850: EXPERT Knotless Round Plate Ø6.5mm (1un) Rectangular Plate 3.3x13.0mm (1un)
• 07899258638843: Mini EXPERT Round Plate Ø5.5mm (1un) Rectangular Plate 2.6x8.0mm (1un)