EDINTRAK 4058A-1

GUDID 07613327364200

Hook Blade

Stryker Trauma SA

Scalpel blade, single-use

• Primary Device ID: 07613327364200
• NIH Device Record Key: 821144e2-13df-4da3-a53e-44a354669a3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDINTRAK
• Version Model Number: 4058A-1
• Catalog Number: 4058A-1
• Company DUNS: 481999654
• Company Name: Stryker Trauma 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07613327364200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940230

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-28

On-Brand Devices [EDINTRAK]

• 37613327364300: Hook Blade
• 07613327364255: Hook Blade
• 37613327364232: Hook Blade
• 07613327364200: Hook Blade
• 07613327363265: Metatarsal Spreader
• 07613327363180: System
• 07613327363159: Micro Elevator
• 07613327362855: Obturator
• 07613327362848: Probe
• 07613327362831: System
• 07613327362770: Micro Blade Handle
• 07613327362749: Cannula
• 07613327362725: Sterilization Tray
• 07613327362688: Obturator
• 07613327362602: Micro Hook Blade
• 07613327362589: Cannula
• 07613327362480: Angled Micro Hook Blade
• 37613327362214: Micro Tip Swabs