Sentry 161-112

GUDID 00190837071172

Pivoting Installer

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190837071172
• NIH Device Record Key: ea575451-16ed-46eb-b6ea-464e0853e6a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentry
• Version Model Number: 161-112
• Catalog Number: 161-112
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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: false
• 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	00190837071172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180166

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

[00190837071172]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Sentry]

• 00190837034597: INSTALLER
• 00190837034542: Fixed Screw, 6.5mm x 40mm
• 00190837034535: Fixed Screw, 6.5mm x 40mm
• 00190837034528: Fixed Screw, 6.5mm x 40mm
• 00190837034511: Fixed Screw, 6.5mm x 40mm
• 00190837034504: Fixed Screw, 6.5mm x 40mm
• 00190837034481: Fixed Screw, 6.5mm x 40mm
• 00190837034474: Fixed Screw, 6.5mm x 40mm
• 00190837034467: Fixed Screw, 6.5mm x 40mm
• 00190837034450: Fixed Screw, 6.5mm x 40mm
• 00190837034436: Sentry ALIF Variable Screw Caddy
• 00190837034412: 50mm Lordosis Sentry ALIF Plate Caddy
• 00190837082772: 169-105
• 00190837071226: Sentry Fixation Pin
• 00190837071219: Sentry Fixation Pin
• 00190837071202: T-25 Ancilliary Driver
• 00190837071196: Installer Driver
• 00190837071189: Set Screw Driver
• 00190837071172: Pivoting Installer
• 00190837071165: 114-317
• 00190837071158: 114-212
• 00190837071141: 114-200
• 00190837034559: TORQUE LIMIT HANDLE, LARGE 1/4" SQ, 6 IN-LB
• 00190837034498: Fixed Screw, 6.5mm x 40mm
• 00190837034443: Sentry ALIF Fixed Screw Caddy
• 00190837034429: 100mm Lordosis Sentry ALIF Plate Caddy
• 00190837034405: Straight Torque Limiting Handle
• 00190837034399: Cam Lock Driver
• 00190837034382: Plate Inserter
• 00190837034375: 1/4 Square Ratcheting Straight Handle
• 00190837034368: T-Handle
• 00190837034351: Variable Screw Caddy
• 00190837034344: Lateral Plate Caddy
• 00190837034337: Sentry Tray Base
• 00190837034320: Sentry Tray Bottom
• 00190837034313: 1/4 Square Ratcheting Straight Handle
• 00190837034306: T-Handle
• 00190837034290: Accessory Box
• 00190837034283: Installer Driver
• 00190837034276: LATERAL PLATE INSTALLER
• 00190837034269: 161-122
• 00190837034252: T30 Hexalobe Driver
• 00190837034245: Osteophyte Removal Tool
• 00190837034238: Ø5.5mm Tap
• 00190837034221: Adjustable Drill
• 00190837034214: Adjustable Awl
• 00190837034207: T25 SCREWDRIVER
• 00190837034191: T-25 Tapered Screwdriver
• 00190837034184: Jacobs Chuck Adapter
• 00190837034177: Torque Limit Handle, Large 1/4" SQ, 25 IN-LB