ROMEO 2 INSTRUMENTATION MIS-IN 06 01-N

GUDID 07640139349453

DILATOR TUBE # 4 RADEL

SpineArt SA

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: 07640139349453
• NIH Device Record Key: c200b8d4-f6c2-420d-8c9a-4da48a40515a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO 2 INSTRUMENTATION
• Version Model Number: MIS-IN 06 01-N
• Catalog Number: MIS-IN 06 01-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	07640139349453 [Primary]

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

[07640139349453]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-24
• Device Publish Date: 2023-03-16

On-Brand Devices [ROMEO 2 INSTRUMENTATION]

• 07640178982253: TAP Ø7 x 30
• 07640178982055: FINAL TIGHTENER 13 HEXAGON
• 07640178982048: FINAL TIGHTENER 13 HEXALOBE
• 07640178982024: TAP Ø6 x 30
• 07640178982017: TAP Ø5 x 30
• 07640178981959: PEDICLE PROBE LENKE STRAIGHT
• 07640178981942: PEDICLE PROBE LENKE CURVED
• 07640178981935: PEDICLE PROBE STRAIGHT
• 07640178981928: DEROTATION HANDLE
• 07640178981850: DRILL Ø3.2
• 07640178981843: ADJUSTABLE DRILL GUIDE
• 07640178981836: DRILL GUIDE
• 07640178981829: ROD TRIAL LONG
• 07640178981812: ROD TRIAL SHORT
• 07640178981805: REAMER
• 07640178981799: SCREWDRIVER SHAFT PS
• 07640178981744: FINE PITCH RATCHETING T-HANDLE
• 07640178981737: FINE PITCH STRAIGHT RATCHETING HANDLE
• 07640178980822: SETSCREW HOLDER H
• 07640178980815: RIBAC L
• 07640178980808: RIBAC R
• 07640178980464: SCREWDRIVER SHAFT PS STRAIGHT
• 07640178980136: TAP Ø 4 X 30
• 07640178980129: TAP Ø 4.5 X 30
• 07640178980112: TAP Ø 6.5 X 30
• 07640178980105: TAP Ø 5.5 X 30
• 07640178979901: 4.0 TIGHTENER
• 07640178975453: TAP Ø7 x 30
• 07640178975446: TAP Ø6 x 30
• 07640178975439: TAP Ø5 x 30
• 07640178975057: COUNTER TORQUE ADAPTED FOR BDYN IMPLANT
• 07640178975033: CLIPPING TUBE OPEN
• 07640178975026: CLIPPING TUBE
• 07640178975019: TROCAR 3 IN 1- LONG TIP AWL
• 07640178974999: QR REDUCER LINK - BRIDGE II
• 07640178974845: QR REDUCER Ti
• 07640178973862: SETSCREW HOLDER
• 07640178973855: FINAL TIGHTENER
• 07640178973848: SETSCREW TIGHTENER
• 07640178973039: COUNTER TORQUE 90°
• 07640178972896: COUNTER TORQUE
• 07640178972889: DRILL Ø 3.2 MM
• 07640178972803: RIBAC
• 07640178972797: QR REDUCER LINK - BRIDGE
• 07640178972780: QR REDUCER LINK
• 07640178972773: QR REDUCER
• 07640178972766: SETSCREW TUBE H
• 07640178972759: DUAL CALIPER
• 07640178972742: SETSCREW HOLDER H
• 07640178972575: VARIABLE ENDTIP ROD HOLDER