Straight Lasso Guide

GUDID G523T1005310

Straight Lasso Guide

Cc-Instruments Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: G523T1005310
• NIH Device Record Key: 830d1b79-5215-4200-8dfb-019197ed94f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Lasso Guide
• Version Model Number: T100531
• Company DUNS: 119059465
• Company Name: Cc-Instruments Inc.
• 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: true
• 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 Dimensions

• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter
• Length: 165 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G523T1005310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232780

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2024-11-25
• Device Publish Date: 2024-11-15

Devices Manufactured by Cc-Instruments Inc.

• G523T1004681 - Sub-Coracoid Clip - Round 10mm: 2024-11-25 Sub-Coracoid Clip - Round 10mm
• G523T1004771 - Sub-Coracoid Clip - Small, Rectangle: 2024-11-25 Sub-Coracoid Clip - Small, Rectangle
• G523T1005151 - Clavicle Clip - 16mm: 2024-11-25 Clavicle Clip - 16mm
• G523T1005161 - Clavicle Clip - 20mm: 2024-11-25 Clavicle Clip - 20mm
• G523T1005200 - Sub-Coracoid Clip - Round 12mm: 2024-11-25 Sub-Coracoid Clip - Round 12mm
• G523T1005220 - Sub-Coracoid Clip - Round 10mm, Curved: 2024-11-25 Sub-Coracoid Clip - Round 10mm, Curved
• G523T1005251 - Sub-Coracoid Clip - Round 12mm, Curved: 2024-11-25 Sub-Coracoid Clip - Round 12mm, Curved
• G523T1005261 - Sub-Coracoid Clip - Small, Rectangle, Curved: 2024-11-25 Sub-Coracoid Clip - Small, Rectangle, Curved