Anterolateral Calcaneus Plate 21064-41

GUDID 09120069812848

Anterolateral Calcaneus Plate, Large

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120069812848
• NIH Device Record Key: beda29aa-12e1-4ccf-bf35-eb14ccba23fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterolateral Calcaneus Plate
• Version Model Number: 21064-41
• Catalog Number: 21064-41
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• 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: 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	09120069812848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051642

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

[09120069812848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-08-08
• Device Publish Date: 2017-12-20

On-Brand Devices [Anterolateral Calcaneus Plate]

• 09120069812862: Anterolateral Calcaneus Plate, Tuber, Large
• 09120069812855: Anterolateral Calcaneus Plate, Tuber, Small
• 09120069812848: Anterolateral Calcaneus Plate, Large
• 09120069812831: Anterolateral Calcaneus Plate, Small