Fixation Screw 70312

GUDID 09120047306345

Fixation Screw, PRS RXsystem

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 09120047306345
• NIH Device Record Key: 0fd2383b-1f67-497e-8744-58e246931f51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Screw
• Version Model Number: 70312
• Catalog Number: 70312
• 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	09120047306345 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

[09120047306345]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-11-11
• Device Publish Date: 2016-11-11

On-Brand Devices [Fixation Screw]

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• 09120047301951: Fixation Screw, Hallux Osteotomy Plate
• 09120047306345: Fixation Screw, PRS RXsystem
• 09120047290026: Fixation Screw, PRS upgrade system