Proximal Medial Tibia Plate 21325-4

GUDID 09120047307311

Proximal Medial Tibia Plate, 4-Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047307311
• NIH Device Record Key: a2884ba4-ef84-40e6-99a4-3ffbf1e759dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Medial Tibia Plate
• Version Model Number: 21325-4
• Catalog Number: 21325-4
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• 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: 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
GS1	09120047307311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093868

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

[09120047307311]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-08
• Device Publish Date: 2016-09-12

On-Brand Devices [Proximal Medial Tibia Plate]

• 09120047307328: Proximal Medial Tibia Plate, 7-Hole
• 09120047307311: Proximal Medial Tibia Plate, 4-Hole