ENDOTRAC 3054-6

GUDID 37613327364348

Triangle Blade

Stryker Trauma SA

Scalpel blade, single-use

• Primary Device ID: 37613327364348
• NIH Device Record Key: adfcd1a3-d861-456e-9d53-718312d8eee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOTRAC
• Version Model Number: 3054-6
• Catalog Number: 3054-6
• 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	07613327364347 [Primary]
GS1	37613327364348 [Package]; Contains: 07613327364347; Package: pack [6 Units]; In Commercial Distribution

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 [ENDOTRAC]

• 37613327364348: Triangle Blade
• 07613327364330: Triangle Blade, Angled
• 07613327364323: Push Blade
• 07613327364316: Push Blade
• 37613327364294: Triangle Blade, Angled
• 07613327364286: Hook/Triangle Blade Kit
• 37613327364270: Hook/Triangle Blade Kit
• 07613327364262: Triangle Blade
• 37613327364249: Hook Blade, Angled
• 37613327364225: Hook/Triangle/Push Blade Kit
• 37613327364218: Triangle Blade
• 37613327364195: Hook Blade, Angled
• 07613327364187: Triangle Blade
• 37613327364171: Hook/Triangle Blade Kit
• 07613327364163: Hook/Triangle Blade Kit
• 37613327364157: Push Blade
• 37613327364133: Hook Blade
• 07613327364125: Hook/Triangle/Push Blade Kit
• 07613327364118: Hook Blade, Angled
• 37613327364096: Hook Blade
• 07613327364088: Hook Blade, Angled
• 37613327364072: Triangle Blade, Angled
• 37613327364065: Push Blade
• 07613327364057: Hook Blade
• 07613327364040: Hook Blade
• 07613327364033: Triangle Blade, Angled
• 07613327356885: Sterilization Tray
• 07613327356861: Retractor
• 07613327356854: Hook/ Triangle/ Push Trio
• 07613327356847: Rasp
• 07613327356830: Probe
• 07613327356823: Blade Handle
• 07613327356540: Angled Hook Blade
• 07613327356533: Slotted Cannula
• 07613327356526: Sterile Hook Blade
• 07613327356519: Gastorcnemius Obturator
• 07613327356496: System
• 07613327356489: Hook/ Triangle Blade Set
• 07613327356472: Blade Handle
• 07613327356458: Probe
• 07613327356434: System
• 07613327356427: EGR KIT
• 07613327356410: Sterile Triangle Blade
• 07613327356403: Fascial Elevator
• 07613327356380: Obturator
• 07613327356373: Sterile Triangle Blade
• 07613327356342: Angled Hook Blade
• 07613327356335: Hook/ Triangle Blade Set
• 07613327356311: Sterile Push Blade
• 07613327356281: Sterile Hook Blade