Laport N21-0510

GUDID 88806182210378

Sejong Medical Co., Ltd

Laparoscopic access cannula, single-use

• Primary Device ID: 88806182210378
• NIH Device Record Key: b204f879-1875-427d-b62f-7f59254a5dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laport
• Version Model Number: N21-0510
• Catalog Number: N21-0510
• Company DUNS: 689850476
• Company Name: Sejong Medical Co., Ltd
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	08806182210372 [Primary]
GS1	18806182210379 [Package]; Contains: 08806182210372; Package: INBOX [10 Units]; In Commercial Distribution
GS1	88806182210378 [Package]; Contains: 18806182210379; Package: CARTON [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171741

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2018-04-05

On-Brand Devices [Laport]

• 88806182210873: N20-0510
• 88806182210583: N23-1210
• 88806182210514: N23-0575
• 08806182210433: N21-1110
• 88806182210392: N21-0575
• 88806182210378: N21-0510
• 88806182210330: N22-0510