234-010-083

GUDID 04546540754783

TUNNEL NOTCHER BIOABSORBABLE ACL SCREW

STRYKER CORPORATION

Orthopaedic bone screw starter/notcher

• Primary Device ID: 04546540754783
• NIH Device Record Key: eef066c4-9922-49ae-9f72-a7ff1f2898c8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 234-010-083
• Catalog Number: 234-010-083
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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: 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540754783 [Primary]

FDA Product Code

• HWD: STARTER, BONE SCREW

Sterilization

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

[04546540754783]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-08-31

Devices Manufactured by STRYKER CORPORATION

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• 07613327627664 - KNOTILUS+: 2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327627701 - KNOTILUS+: 2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327623796 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HIP
• 07613327623833 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
• 07613327634686 - Iconix: 2024-03-12 Iconix DC Guide for 1.4mm anchor
• 07613327634693 - Iconix: 2024-03-12
• 07613327616675 - SPY: 2024-03-06