Spike Short 70314

GUDID 09120047306369

Spike Short, PRS RX system

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 09120047306369
• NIH Device Record Key: b82ca7bc-e855-4060-a8ae-5903ae6cec44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spike Short
• Version Model Number: 70314
• Catalog Number: 70314
• 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	09120047306369 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

Moist Heat or Steam Sterilization

[09120047306369]

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 [Spike Short]

• 09120047306369: Spike Short, PRS RX system
• 09120047297742: Spike Short, PRS upgrade system