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

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• B354HAF2SHS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Large: 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Large Heart Assist, Sing Use, 2 Finger Short, Malleable 36mm x 54mm
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