Fenestrated Long Inner Shaft 43cm

GUDID B354339

Fenestrated Long Inner Shaft 43cm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354339
• NIH Device Record Key: d5dcc759-47b9-4b7f-9f29-e5e230da6cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated Long Inner Shaft 43cm
• Version Model Number: C339B
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 90
• 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	B354339 [Unit of Use]
HIBCC	B354C3391 [Primary]
HIBCC	B354C3392 [Primary]
HIBCC	B354C3393 [Primary]
HIBCC	B354C3394 [Primary]
HIBCC	B354C3395 [Primary]
HIBCC	B354C3399 [Primary]
HIBCC	B354C339B1 [Primary]
HIBCC	B354C339B2 [Primary]
HIBCC	B354C339B3 [Primary]
HIBCC	B354C339B4 [Primary]
HIBCC	B354C339B5 [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

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

Devices Manufactured by ORANGE SURGICAL INSTRUMENTS, LLC

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• 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