3 Ring Suture Passer Kit with 10/12mm and 15mm Guides OS3CDK15

GUDID B354OS3CDK15

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread

• Primary Device ID: B354OS3CDK15
• NIH Device Record Key: 9668bdf4-c165-4d3d-a789-61a470a18f9d
• Commercial Distribution Discontinuation: 2023-08-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• Version Model Number: OS3CDK15
• Catalog Number: OS3CDK15
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• 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: true
• 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
HIBCC	B354OS3CDK15 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [3 Ring Suture Passer Kit with 10/12mm and 15mm Guides]

• B354OS3CDK15: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• B354OS3CDK1500: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• B354OS3CDK150: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides