ROMEO 2 PAD INSTRUMENTATION PAD-IN 02 12-N

GUDID 07640139349262

Trial Implant Size 12

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640139349262
• NIH Device Record Key: 555f4cd7-31f0-4065-a59c-9b3fc905bd0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 PAD INSTRUMENTATION
• Version Model Number: PAD-IN 02 12-N
• Catalog Number: PAD-IN 02 12-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	07640139349262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141508

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

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

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

[07640139349262]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-27

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