Universal Distal Radius CT2.8L28D-ST

GUDID 03700569657857

NEWCLIP TECHNICS

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03700569657857
• NIH Device Record Key: 073a75ef-27e9-49c7-956e-ea686d3ebcdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Distal Radius
• Version Model Number: CT2.8L28D-ST
• Catalog Number: CT2.8L28D-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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700569657857 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Universal Distal Radius]

• 03700569657857: CT2.8L28D-ST
• 03700569657840: CT2.8L28D
• 03700569657833: CT2.8L26D-ST
• 03700569657826: CT2.8L26D
• 03700569657819: CT2.8L24D-ST
• 03700569657802: CT2.8L24D
• 03700569657796: CT2.8L22D-ST
• 03700569657789: CT2.8L22D
• 03700569657772: CT2.8L20D-ST
• 03700569657765: CT2.8L20D
• 03700569657758: CT2.8L18D-ST
• 03700569657741: CT2.8L18D
• 03700569657734: CT2.8L16D-ST
• 03700569657710: CT2.8L14D-ST
• 03700569657703: CT2.8L14D
• 03700569657697: CT2.8L12D-ST
• 03700569657680: CT2.8L12D
• 03700569657673: CT2.8L10D-ST
• 03700569657666: CT2.8L10D