8mm x 16mm Foam Sleeves

GUDID B354CCS8160

8mm x 16mm Foam Sleeves

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B354CCS8160
• NIH Device Record Key: 4b2a7a27-f368-45e4-8cfd-5df824d04d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8mm x 16mm Foam Sleeves
• Version Model Number: CCS816
• 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	B354CCS8160 [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

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

[B354CCS8160]

Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-29
• Device Publish Date: 2024-02-21

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