EASYSTEP EZS-10

GUDID 07613327135213

Step (10mm) Staple

Stryker Trauma SA

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 07613327135213
• NIH Device Record Key: ffc6a02b-348b-4dcc-ad50-fc67b96359e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EASYSTEP
• Version Model Number: EZS-10
• Catalog Number: EZS-10
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07613327135213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160813

FDA Product Code

• JDR: Staple, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-08-25

On-Brand Devices [EASYSTEP]

• 07613327283648: Spare Parts Drill Guide
• 07613327283624: Spare Parts Forceps
• 07613327173277: Labeling Clip
• 07613327170993: Impactor
• 07613327170894: Adjustable Drill Guide
• 07613327170849: Silicon Mat
• 07613327170818: Adjustable Forceps
• 07613327170757: Positioning Pin
• 07613327170740: Metal Tray
• 07613327170726: Drill Bit with Stop
• 07613327135244: Step (6mm) Staple
• 07613327135237: Step (12mm) Staple
• 07613327135220: Step (8mm) Staple
• 07613327135213: Step (10mm) Staple
• 07613327135190: Step (4mm) Staple