Handle for 10mm

GUDID B3544440

Handle for 10mm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B3544440
• NIH Device Record Key: c47ba0b5-6f59-4e32-9cbd-17bb4cd513ab
• Commercial Distribution Discontinuation: 2023-08-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Handle for 10mm
• Version Model Number: 444
• 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: true
• Lot Batch: true
• 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	B3544440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101733

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [Handle for 10mm]

• B3544450: Handle for 10mm
• B3544440: Handle for 10mm