Fenestrated Long Inner Shaft 44cm 339B

GUDID B354339B0

Fenestrated Long Inner Shaft 44cm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B354339B0
• NIH Device Record Key: 0877c32e-a6ab-4545-8f66-5ad7f057e8fc
• Commercial Distribution Discontinuation: 2021-03-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated Long Inner Shaft 44cm
• Version Model Number: 339B
• Catalog Number: 339B
• 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: 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	B354339B0 [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

[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

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[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

[B354339B0]

Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-30
• Device Publish Date: 2018-03-29

On-Brand Devices [Fenestrated Long Inner Shaft 44cm]

• B354339B0: Fenestrated Long Inner Shaft 44cm
• B354C339B0: Fenestrated Long Inner Shaft 44cm