Reusable Ratchet Handle - tips 34cm each

GUDID B35431

Reusable Ratchet Handle - tips 34cm each

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B35431
• NIH Device Record Key: f702b3e3-7055-4286-936c-d1b0f1571931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Ratchet Handle - tips 34cm each
• Version Model Number: B354OS3R
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 99999
• 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	B35431 [Unit of Use]
HIBCC	B354OS3CD1 [Primary]
HIBCC	B354OS3CD2 [Primary]
HIBCC	B354OS3CD3 [Primary]
HIBCC	B354OS3CD4 [Primary]
HIBCC	B354OS3CD5 [Primary]
HIBCC	B354OS3CD9 [Primary]
HIBCC	B354OS3CDB1 [Primary]
HIBCC	B354OS3CDB2 [Primary]
HIBCC	B354OS3CDB3 [Primary]
HIBCC	B354OS3CDB4 [Primary]
HIBCC	B354OS3CDB5 [Primary]
HIBCC	B354OS3CDB9 [Primary]
HIBCC	B354OS3R1 [Primary]
HIBCC	B354OS3R2 [Primary]
HIBCC	B354OS3R3 [Primary]
HIBCC	B354OS3R4 [Primary]
HIBCC	B354OS3R5 [Primary]
HIBCC	B354OS3R9 [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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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

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[B35431]

Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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Peracetic Acid

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[B35431]

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[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

[B35431]

Peracetic Acid

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-08

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