Xpert Wrist CAT3.5L10D

GUDID 03700569654290

NEWCLIP TECHNICS

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03700569654290
• NIH Device Record Key: dd57829a-746a-4c2d-8b2e-004068a321a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert Wrist
• Version Model Number: CAT3.5L10D
• Catalog Number: CAT3.5L10D
• Company DUNS: 263281904
• Company Name: NEWCLIP TECHNICS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700569654290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213214

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

[03700569654290]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Xpert Wrist]

• 03700569654382: CAT3.5L18D-ST
• 03700569654375: CAT3.5L18D
• 03700569654368: CAT3.5L16D-ST
• 03700569654351: CAT3.5L16D
• 03700569654344: CAT3.5L14D-ST
• 03700569654337: CAT3.5L14D
• 03700569654320: CAT3.5L12D-ST
• 03700569654313: CAT3.5L12D
• 03700569654306: CAT3.5L10D-ST
• 03700569654290: CAT3.5L10D
• 03700569642402: BDT1.8L26-ST
• 03700569642396: BDT1.8L24-ST
• 03700569642389: BDT1.8L22-ST
• 03700569642372: BDT1.8L20-ST
• 03700569642365: BDT1.8L18-ST
• 03700569642358: BDT1.8L16-ST
• 03700569642341: BDT1.8L14-ST
• 03700569642334: BDT1.8L26
• 03700569642327: BDT1.8L24
• 03700569642310: BDT1.8L22
• 03700569642303: BDT1.8L20
• 03700569642297: BDT1.8L18
• 03700569642280: BDT1.8L16
• 03700569642273: BDT1.8L14