J-Pass Suture Passer

GUDID 00860366001406

Suture passer used for passing suture around boney structures.

CORACOID SOLUTIONS LLC

Suturing unit, single-use

• Primary Device ID: 00860366001406
• NIH Device Record Key: b4abbe95-65bf-4404-b3f1-cfd663ae831b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J-Pass Suture Passer
• Version Model Number: FG1001
• Company DUNS: 073670228
• Company Name: CORACOID SOLUTIONS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00860366001406 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-06-18

Devices Manufactured by CORACOID SOLUTIONS LLC

• 00860366001406 - J-Pass Suture Passer: 2020-02-06Suture passer used for passing suture around boney structures.
• 00860366001406 - J-Pass Suture Passer: 2020-02-06 Suture passer used for passing suture around boney structures.
• 00860366001413 - M-Fix 4mm: 2018-07-19 The M-Fix is designed to provide reduction and stabilization of the acromioclavicular joint while providing a simpler, streamlin
• 00860366001420 - M-Fix 7mm: 2018-07-19 Surgical implant to reduce and stabilize the acromioclavicular joint.