3 Ring Suture Passer - Kit OS3CDK

GUDID B354OS3CDK0

3 Ring Suture Passer - Kit

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread

• Primary Device ID: B354OS3CDK0
• NIH Device Record Key: 154ae3cd-8dc3-4146-a455-33a67e1f2fc6
• Commercial Distribution Discontinuation: 2021-03-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Ring Suture Passer - Kit
• Version Model Number: OS3CDK
• Catalog Number: OS3CDK
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B354OS3CDK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

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: 2018-04-30
• Device Publish Date: 2018-03-28

On-Brand Devices [3 Ring Suture Passer - Kit]

• B354OS3CDK0: 3 Ring Suture Passer - Kit
• B354OS3CDKS0: 3 Ring Suture Passer - Kit with 5mm and 10mm swab