ROMEO 2 PAD INSTRUMENTATION PAD-IN 11 00-N

GUDID 07640178972155

Multiaxial Plate Inserter

SpineArt SA

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 07640178972155
• NIH Device Record Key: 31de1a57-f0d0-4842-8698-0b9e68032097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 PAD INSTRUMENTATION
• Version Model Number: PAD-IN 11 00-N
• Catalog Number: PAD-IN 11 00-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: false
• Manufacturing Date: true
• 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	07640178972155 [Primary]

FDA Product Code

• HXX: Screwdriver

Sterilization

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

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

[07640178972155]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2018-07-31

On-Brand Devices [ROMEO 2 PAD INSTRUMENTATION]

• 07640178975040: Spinous process compression forceps
• 07640178973756: Compression forceps
• 07640178972155: Multiaxial Plate Inserter
• 07640178972148: Locking Plate Inserter
• 07640151095048: Spinous process compression forceps
• 07640151092153: Multiaxial Plate Inserter
• 07640151092146: Locking Plate Inserter
• 07640151081874: Trial Implant Size 18
• 07640151081867: Trial Implant Size 16
• 07640139349323: Revision screwdriver
• 07640139349309: Compactor
• 07640139349293: Compaction Base
• 07640139349286: Implant Holder
• 07640139349279: Trial Implant Size 14
• 07640139349262: Trial Implant Size 12
• 07640139349255: Trial Implant Size 10
• 07640139349248: Trial Implant Size 08
• 07640178989269: EMPTY INSTRUMENTS TRAY