ROMEO® 2 SPE-US 00 53-N

GUDID 07640185348585

MODULAR SPLIT TIP SETSCREW STARTER

SpineArt SA

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 07640185348585
• NIH Device Record Key: 3cfb384c-a429-4d5e-8c8a-ffa734ba2f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO® 2
• Version Model Number: SPE-US 00 53-N
• Catalog Number: SPE-US 00 53-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 Dimensions

• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 255 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640185348585 [Primary]

FDA Product Code

• HWR: Driver, Prosthesis

Sterilization

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

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

[07640185348585]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-07
• Device Publish Date: 2021-06-29

On-Brand Devices [ROMEO® 2]

• 07640185348585: MODULAR SPLIT TIP SETSCREW STARTER
• 07640151088323: CEMENT FILLER PP