Spike 70301-7

GUDID 09120034300196

Spike, WS 7, PRS Set

I.T.S. GmbH

Orthopaedic ball spike

• Primary Device ID: 09120034300196
• NIH Device Record Key: a36b80f3-d95a-439a-b858-ff005e6294d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spike
• Version Model Number: 70301-7
• Catalog Number: 70301-7
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120034300196 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

[09120034300196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-01
• Device Publish Date: 2018-10-24

Devices Manufactured by I.T.S. GmbH

• 09120034304392 - Washer, Flat: 2024-11-11 Washer, Flat, AD=14,0mm, ID=7,0mm
• 09120047290026 - Fixation Screw: 2024-11-11 Fixation Screw, PRS upgrade system
• 09120047290071 - Bolt: 2024-11-11 Bolt, PRS upgrade system
• 09120047297742 - Spike Short: 2024-11-11 Spike Short, PRS upgrade system
• 09120047306345 - Fixation Screw: 2024-11-11 Fixation Screw, PRS RXsystem
• 09120047306352 - Bolt: 2024-11-11 Bolt, PRS RX System
• 09120047306369 - Spike Short: 2024-11-11 Spike Short, PRS RX system
• 09120034300196 - Spike: 2024-10-01Spike, WS 7, PRS Set
• 09120034300196 - Spike: 2024-10-01 Spike, WS 7, PRS Set