3 Ring Suture Passer - 18 cm Bariatric OS3CDB

GUDID B354OS3CDB0

3 Ring Suture Passer - 18 cm Bariatric

ORANGE SURGICAL INSTRUMENTS, LLC

Laparoscopic wound closure thread

• Primary Device ID: B354OS3CDB0
• NIH Device Record Key: fa536b29-03b3-4359-9786-f3b40f8c0a11
• Commercial Distribution Discontinuation: 2021-03-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Ring Suture Passer - 18 cm Bariatric
• Version Model Number: OS3CDB
• Catalog Number: OS3CDB
• 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	B354OS3CDB0 [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

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