Calcaneus Plate 21061-60

GUDID 09120034303135

Calcaneus Plate, Long

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034303135
• NIH Device Record Key: fbdac60e-6132-4901-bf2c-9bc053742862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcaneus Plate
• Version Model Number: 21061-60
• Catalog Number: 21061-60
• 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	09120034303135 [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

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

[09120034303135]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-07

On-Brand Devices [Calcaneus Plate]

• 09120034309878: Calcaneus Plate, Medium
• 09120034308512: Calcaneus Plate, Long
• 09120034308505: Calcaneus Plate, Short
• 09120034303142: Calcaneus Plate, Short
• 09120034303135: Calcaneus Plate, Long