EASYCLIP EZXP18-17-15

GUDID 07613327358001

Xpress Staple (18 x 17 x 15mm)

Stryker Trauma SA

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 07613327358001
• NIH Device Record Key: 009bc9fe-f426-4a04-8171-3c00314901e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EASYCLIP
• Version Model Number: EZXP18-17-15
• Catalog Number: EZXP18-17-15
• 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: true
• 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	07613327358001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162321

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-18

On-Brand Devices [EASYCLIP]

• 07613327364682: Staple Sizer
• 07613327358049: Xpress Staple (18 x 14 x 14mm)
• 07613327358032: Xpress Staple (12 x 10 x 10mm)
• 07613327358025: Xpress Staple (10 x 10 x 10mm)
• 07613327358001: Xpress Staple (18 x 17 x 15mm)
• 07613327357998: Xpress Staple (15 x 12 x 12mm)
• 07613327357974: Xpress Staple (18 x 19 x 17mm)
• 07613327357967: Xpress Staple (25 x 22 x 22mm)
• 07613327357950: Xpress Staple (20 x 20 x 20mm)
• 07613327357943: Xpress Staple (20 x 16 x 16mm)
• 07613327357936: Xpress Staple (15 x 15 x 15mm)
• 07613327357929: Xpress Staple (10 x 15 x 13mm)
• 07613327357912: Xpress Staple (8 x 8 x 8mm)
• 07613327357905: Xpress Staple (12 x 15 x 13mm)
• 07613252266266: Tray
• 07613252257332: Viewfinder sleeve
• 07613252266365: Cover / Lid
• 07613252266013: Forceps - Size 18
• 07613252266006: Forceps - Size 12
• 07613252265993: Forceps - Size 10
• 07613252257172: Fixed staple drill guide head - Size 20
• 07613252257165: Fixed staple drill guide head - Size 25
• 07613252257158: Fixed staple drill guide head - Size 18
• 07613252257141: Fixed staple drill guide head - Size 12
• 07613252257134: Fixed staple drill guide head - Size 15
• 07613252257127: Fixed staple drill guide head - Size 8
• 07613252257110: Fixed staple drill guide head - Size 10