3 Ring Suture Passer Kit with 10/12mm and 15mm Guides

GUDID B354OS3CDK1500

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B354OS3CDK1500
• NIH Device Record Key: 14560d3a-9cac-4c13-9ce0-058d9bdfdc2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• Version Model Number: B354OS3CDK15
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 99999
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	B354OS3CDK1500 [Unit of Use]
HIBCC	B354OS3CDK151 [Primary]
HIBCC	B354OS3CDK152 [Primary]
HIBCC	B354OS3CDK153 [Primary]
HIBCC	B354OS3CDK154 [Primary]
HIBCC	B354OS3CDK155 [Primary]
HIBCC	B354OS3CDK159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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[B354OS3CDK1500]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [3 Ring Suture Passer Kit with 10/12mm and 15mm Guides]

• B354OS3CDK15: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• B354OS3CDK1500: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
• B354OS3CDK150: 3 Ring Suture Passer Kit with 10/12mm and 15mm Guides