Fibula Plate Distal, 5-Hole 21223-5

GUDID 09120069817089

Fibula Plate Distal, 5-Hole, Right

I.T.S. GmbH

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 09120069817089
• NIH Device Record Key: 057fe0be-52cd-4c7c-93b2-0b5e79358f1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibula Plate Distal, 5-Hole
• Version Model Number: 21223-5
• Catalog Number: 21223-5
• 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	09120069817089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063672

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

[09120069817089]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-28
• Device Publish Date: 2020-04-20

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