Monopolar Alligator Padded Grasper, 33cm Disposable

GUDID B35410

Monopolar Alligator Padded Grasper, 33cm Disposable

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B35410
• NIH Device Record Key: 2a599a64-9a19-4b5f-bdcd-9ebf5fec7ac4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar Alligator Padded Grasper, 33cm Disposable
• Version Model Number: B354OSAPGD
• Company DUNS: 047063695
• Company Name: ORANGE SURGICAL INSTRUMENTS, LLC
• Device Count: 5
• 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	B35410 [Unit of Use]
HIBCC	B354OSAFG1 [Primary]
HIBCC	B354OSAFG2 [Primary]
HIBCC	B354OSAFG3 [Primary]
HIBCC	B354OSAFG4 [Primary]
HIBCC	B354OSAFG5 [Primary]
HIBCC	B354OSAFG9 [Primary]
HIBCC	B354OSAFGL1 [Primary]
HIBCC	B354OSAFGL2 [Primary]
HIBCC	B354OSAFGL3 [Primary]
HIBCC	B354OSAFGL4 [Primary]
HIBCC	B354OSAFGL5 [Primary]
HIBCC	B354OSAFGL9 [Primary]
HIBCC	B354OSAPG1 [Primary]
HIBCC	B354OSAPG2 [Primary]
HIBCC	B354OSAPG3 [Primary]
HIBCC	B354OSAPG4 [Primary]
HIBCC	B354OSAPG5 [Primary]
HIBCC	B354OSAPG9 [Primary]
HIBCC	B354OSAPGD1 [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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[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

Peracetic Acid

[B35410]

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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