Outer Shaft for Reusable Instrument OS5C

GUDID B354OS5C0

Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B354OS5C0
• NIH Device Record Key: 2b29aade-b58f-4fd9-95d5-6e15876a5575
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Outer Shaft for Reusable Instrument
• Version Model Number: OS5C
• Catalog Number: OS5C
• 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: 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	B354OS5C0 [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

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

[B354OS5C0]

Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-24
• Device Publish Date: 2021-08-16

On-Brand Devices [Outer Shaft for Reusable Instrument ]

• B354OS50: Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric
• B354COS50: Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric
• B354OS5C0: Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric