390016S

GUDID 04546540430298

Washer

Stryker Trauma SA

Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

• Primary Device ID: 04546540430298
• NIH Device Record Key: d6faeb32-c77a-4fc0-80cf-29398b17aa61
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 390016S
• Catalog Number: 390016S
• 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	04546540430298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001614

FDA Product Code

• KTW: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

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: 2015-09-24

Devices Manufactured by Stryker Trauma SA

• 07613327615050 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, std., R
• 07613327615111 - VARIAX: 2024-05-15 Volar DR Aiming Block, narrow, R
• 07613327615203 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, R
• 07613327615234 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, std., L
• 07613327615425 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, L
• 07613327615517 - VARIAX: 2024-05-15 Volar DR Aiming Block, wide, L
• 07613327615579 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, narr., L
• 07613327615630 - VARIAX: 2024-05-15 Volar DR Aiming Block, narrow, L