TRIAX 5150-0-070

GUDID 07613327083705

Dynamic Tube Assembly Blue

Stryker Trauma SA

External orthopaedic fixation system, reusable

• Primary Device ID: 07613327083705
• NIH Device Record Key: 7cf20f15-a557-44d8-bf5b-5376f86eb71b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIAX
• Version Model Number: 5150-0-070
• Catalog Number: 5150-0-070
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: true
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327083705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930836

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[07613327083705]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-24

On-Brand Devices [TRIAX]

• 07613327095029: Tube to Tube Clamp;Yellow/Blue
• 07613327095012: Tube to Tube Clamp; Yellow/Yellow
• 07613327095005: Tube to Tube Clamp; Red/Red
• 07613327094992: Tube to tube Clamp; Blue/Red
• 07613327094985: Tube to Tube Clamp; Blue/Blue
• 07613327092301: Single Pin Clamp; Yellow
• 07613327092295: Single Pin Clamp; Red
• 07613327092288: Single Pin Clamp; Blue
• 07613327087819: T-Adaptor Clamp; Blue
• 07613327087772: T-Adaptor Clamp; Yellow
• 07613327087765: T-Adaptor Clamp; Red
• 07613327083774: Dynamic Tube; Red
• 07613327083750: Dynamic Tube Assembly Yellow
• 07613327083743: Dynamic Tube; Yellow
• 07613327083736: Dynamic Tube; Blue
• 07613327083729: Dynamic Tube Assembly Red
• 07613327083705: Dynamic Tube Assembly Blue
• 07613327079067: Carbon Tube; Yellow
• 07613327079050: Carbon Tube; Yellow
• 07613327079043: Carbon Tube; Yellow
• 07613327079036: Carbon Tube; Yellow
• 07613327079029: Carbon Tube; Red
• 07613327079012: Carbon Tube; Red
• 07613327079005: Carbon Tube; Red
• 07613327078992: Carbon Tube; Red
• 07613327078985: Carbon Tube; Blue
• 07613327078978: Carbon Tube; Blue
• 07613327078961: Carbon Tube; Blue
• 07613327078954: Carbon Tube; Blue
• 07613327078947: Carbon Tube End Cap Yellow
• 07613327078930: Carbon Tube End Cap Red
• 07613327078923: Carbon Tube End Cap Blue
• 07613327072839: 4 Hole Pin Clamp; Red
• 07613327072822: 4 Hole Pin Clamp; Blue
• 07613327072785: 2 Hole Pin Clamp; Yellow
• 07613327087512: Storage Case Yellow
• 07613327093360: Storage Case Blue / Red
• 07613327091434: Reduction Handle; Blue/Red
• 07613327088946: O-RING A+P ORM.0100.15
• 07613327088892: O-RING FOR END CAP RED Diam. 25mm
• 07613327088878: O-RING FOR END CAP BLUE Diam. 20mm