OVERWATCH

GUDID 00840916161699

CORONAL BENDER RIGHT

SPINAL ELEMENTS

Orthopaedic prosthesis implantation 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