Lap Port Closure Device Bariatric Kit OSLPCDBKS

GUDID B354OSLPCDBKS0

Lap Port Closure Device Bariatric Kit with 5mm and 10mm swab

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread

• Primary Device ID: B354OSLPCDBKS0
• NIH Device Record Key: 98f65486-1931-49fa-939d-a53ebce341fb
• Commercial Distribution Discontinuation: 2023-03-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lap Port Closure Device Bariatric Kit
• Version Model Number: OSLPCDBKS
• Catalog Number: OSLPCDBKS
• 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	B354OSLPCDBKS0 [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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [Lap Port Closure Device Bariatric Kit]

• B354OSLPCDBK0: Lap Port Closure Device Bariatric Kit
• B354OSLPCDBKS0: Lap Port Closure Device Bariatric Kit with 5mm and 10mm swab