Insufflation Fitler & Tubing Set w/Combo 15/22 Connector Heat Activated OS-IT-L1522H

GUDID B354OSITL1522H10

Insufflation Fitler & Tubing Set w/Combo 15/22 Connector Heat Activated

ORANGE SURGICAL INSTRUMENTS, LLC

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• Primary Device ID: B354OSITL1522H10
• NIH Device Record Key: 9b12c514-ab18-4803-8fad-b050c15707dc
• Commercial Distribution Discontinuation: 2019-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Insufflation Fitler & Tubing Set w/Combo 15/22 Connector Heat Activated
• Version Model Number: OS-IT-L1522H
• Catalog Number: OS-IT-L1522H
• 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	B354OSITL1522H0 [Primary]
HIBCC	B354OSITL1522H10 [Package]; Contains: B354OSITL1522H0; Package: [10 Units]; Discontinued: 2019-11-15; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-15
• Device Publish Date: 2016-11-15

Devices Manufactured by ORANGE SURGICAL INSTRUMENTS, LLC

• B354OSLPCDG0 - Lap-port closure device guides 5mm and 10/12 mm: 2024-03-15 Lap-port closure device guides 5mm and 10/12 mm
• B354OS349440 - Needle Holder Straight 44cm: 2024-03-12 Needle Holder Straight 44cm
• B354CCBF14100 - Baton 10mm Foam: 2024-02-29 Baton 10mm Foam
• B354CCBF1450 - Baton 5mm Foam: 2024-02-29 Baton 5mm Foam
• B354CCLCS50 - Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft: 2024-02-29 Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 5mm Shaft
• B354CCLCS80 - Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft: 2024-02-29 Lens Cleaner 5mm - 10/12mm Batons with Foam Sleeve for 8mm Shaft
• B354CCS50 - Lens Cleaner Foam Sleeve for 5mm Shaft: 2024-02-29 Lens Cleaner Foam Sleeve for 5mm Shaft
• B354CCS5100 - 5mm x 10mm Foam Sleeves: 2024-02-29 5mm x 10mm Foam Sleeves