OVERWATCH

GUDID 00840916161699

CORONAL BENDER RIGHT

SPINAL ELEMENTS

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00840916161699
• NIH Device Record Key: 3e48c2a2-24b0-46f9-b1a7-28f45c50a076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OVERWATCH
• Version Model Number: ACB-000004HCR
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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	00840916161699 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

[00840916161699]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

On-Brand Devices [OVERWATCH]

• 00840916134686: Quick Lock Screw Driver, Short Inner Shaft
• 00840916134822: Clip On Reducer Sleeve
• 00840916134792: Quick Lock Screw Driver, Handle
• 00840916134693: QUICK LOCK SCREW DRIVER OUTER SLEEVE SHORT
• 00840916131821: OVERWATCH® 5.5MM x 50MM MIS POLY EXTENDED TAB CANNULATED SCREW
• 00840916131777: Overwatch 7.5MM x 55MM Dualfix Cannulated Screw Assy, Low Top
• 00840916131739: Overwatch 7.5MM x 35MM Dualfix Cannulated Screw Assy, Low Top
• 00840916131654: Overwatch 8.5MM x 70MM Dualfix Screw Assy, Low Top
• 00840916131630: Overwatch 8.5MM x 60MM Dualfix Screw Assy, Low Top
• 00840916131623: Overwatch 8.5MM x 55MM Dualfix Screw Assy, Low Top
• 00840916131449: Overwatch 7.5MM x 55MM Cannulated Screw Assy, Low Top
• 00840916131272: Rev Conn Open Closed SBS
• 00840916131265: Rev Conn Closed SBS
• 00840916131258: Rev Conn End To End
• 00840916131241: Rev Conn SBS Open
• 00840916131180: 190MM Overwatch MIS Rod
• 00840916131104: 130MM Overwatch MIS Rod
• 00840916131098: 125MM Overwatch MIS Rod
• 00840916131043: 100MM Overwatch MIS Rod
• 00840916131012: 85MM Overwatch MIS Rod
• 00840916130978: 65MM Overwatch MIS Rod
• 00840916130961: 60MM Overwatch MIS Rod
• 00840916130954: 55MM Overwatch MIS Rod
• 00840916130923: 40MM Overwatch MIS Rod
• 00840916130480: Overwatch 9.5MM x 35MM Low Top Pedicle Screw
• 00840916130473: Overwatch 9.5MM x 30MM Low Top Pedicle Screw
• 00840916130466: Overwatch 9.5MM x 25MM Low Top Pedicle Screw
• 00840916130459: Overwatch 9.5MM x 110MM Low Top Pedicle Screw
• 00840916130442: Overwatch 9.5MM x 105MM Low Top Pedicle Screw
• 00840916130435: Overwatch 9.5MM x 100MM Low Top Pedicle Screw
• 00840916130411: Overwatch 8.5MM x 90MM Low Top Pedicle Screw
• 00840916130404: Overwatch 8.5MM x 85MM Low Top Pedicle Screw
• 00840916130381: Overwatch 8.5MM x 75MM Low Top Pedicle Screw
• 00840916130374: Overwatch 8.5MM x 70MM Low Top Pedicle Screw
• 00840916130367: Overwatch 8.5MM x 65MM Low Top Pedicle Screw
• 00840916130343: Overwatch 8.5MM x 55MM Low Top Pedicle Screw
• 00840916130190: Overwatch 7.5MM x 70MM Low Top Pedicle Screw
• 00840916130183: Overwatch 7.5MM x 65MM Low Top Pedicle Screw
• 00840916130138: Overwatch 7.5MM x 40MM Low Top Pedicle Screw
• 00840916132712: Overwatch 7.5MM x 45MM Dualfix Reduction Screw
• 00840916132569: Overwatch 9.5MM x 90MM Sagittal Reduction Screw
• 00840916132552: Overwatch 9.5MM x 85MM Sagittal Reduction Screw
• 00840916132064: OVERWATCH® 7.5MM x 55MM MIS POLY EXTENDED TAB CANNULATED SCREW
• 00840916132057: OVERWATCH® 7.5MM x 50MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916132040: OVERWATCH® 7.5MM x 45MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916132026: OVERWATCH® 7.5MM x 35MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916132019: OVERWATCH® 6.5MM x 55MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916132002: OVERWATCH® 6.5MM x 50MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916131999: OVERWATCH® 6.5MM x 45MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW
• 00840916131982: OVERWATCH® 6.5MM x 40MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW