SDT2.8L10-ST

GUDID 03700569604752

NEWCLIP TECHNICS

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03700569604752
• NIH Device Record Key: 8b17e56d-25e7-40df-b794-cb3dc1ba39e0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SDT2.8L10-ST
• Catalog Number: SDT2.8L10-ST
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700569604752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130774

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: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-09-28

Devices Manufactured by NEWCLIP TECHNICS

• 03700569600839 - NA: 2024-02-19
• 03700569600846 - NA: 2024-02-19
• 03700569600853 - NA: 2024-02-19
• 03700569600860 - NA: 2024-02-19
• 03700569600877 - NA: 2024-02-19
• 03700569600884 - NA: 2024-02-19
• 03700569601027 - NA: 2024-02-19
• 03700569601188 - NA: 2024-02-19