Locking Handle OS6000R

GUDID B354OS5D60000

Locking/Ratcheting Handle

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354OS5D60000
• NIH Device Record Key: 33410101-b8ef-40dd-8ca8-240f33f3f22b
• Commercial Distribution Discontinuation: 2019-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Locking Handle
• Version Model Number: OS-5-D6000
• Catalog Number: OS6000R
• 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: false
• 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	B354OS5D60000 [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

[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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[B354OS5D60000]

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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

On-Brand Devices [Locking Handle]

• B354OS5D60000: Locking/Ratcheting Handle
• B354OSC6000: Regular Handle