Curved Metzenbaum Scissor Shaft insert, 33 cm, Disposable 10 per box

GUDID B354335

Curved Metzenbaum Scissor Shaft insert, 33 cm, Disposable 10 per box

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B354335
• NIH Device Record Key: 0d8ab0c3-0628-41c1-83d5-d4d8805253ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Metzenbaum Scissor Shaft insert, 33 cm, Disposable 10 per box
• Version Model Number: B354OS335MCMSI
• 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	B354335 [Unit of Use]
HIBCC	B354C3351 [Primary]
HIBCC	B354C3352 [Primary]
HIBCC	B354C3353 [Primary]
HIBCC	B354C3354 [Primary]
HIBCC	B354C3355 [Primary]
HIBCC	B354C3359 [Primary]
HIBCC	B354OS335MCMSI1 [Primary]
HIBCC	B354OS335MCMSI2 [Primary]
HIBCC	B354OS335MCMSI3 [Primary]
HIBCC	B354OS335MCMSI4 [Primary]
HIBCC	B354OS335MCMSI5 [Primary]
HIBCC	B354OS335MCMSI9 [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

[B354335]

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Device Entry Metadata

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

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