Lap Port Closure Device Bariatric Kit OSLPCDBK

GUDID B354OSLPCDBK0

Lap Port Closure Device Bariatric Kit

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread Laparoscopic wound closure thread

• Primary Device ID: B354OSLPCDBK0
• NIH Device Record Key: 34600bd7-5e52-46f1-8c9c-aa17c29b479c
• Commercial Distribution Discontinuation: 2021-03-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lap Port Closure Device Bariatric Kit
• Version Model Number: OSLPCDBK
• Catalog Number: OSLPCDBK
• 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	B354OSLPCDBK0 [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 [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