Lap-port closure device guides 5mm and 10/12 mm

GUDID B354OSLPCDG0

Lap-port closure device guides 5mm and 10/12 mm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354OSLPCDG0
• NIH Device Record Key: f9a445ea-e71b-4c0a-9a17-c1b38fd7b6ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lap-port closure device guides 5mm and 10/12 mm
• Version Model Number: OSLPCD510/12
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B354OSLPCDG0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [Lap-port closure device guides 5mm and 10/12 mm]

• B354OSLPCDG5101210: Lap-port closure device guides 5mm and 10/12 mm
• B354OSLPCDG0: Lap-port closure device guides 5mm and 10/12 mm