234-010-054

GUDID 04546540754547

UNIVERSAL WEDGE 8MM X 25MM (1.5MM BORE)

STRYKER CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 04546540754547
• NIH Device Record Key: 41386ed4-00fe-446b-8634-c7efc9d1bead
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 234-010-054
• Catalog Number: 234-010-054
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 25 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540754547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972233

FDA Product Code

• HWC: Screw, 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: 2015-09-09

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