Needle Holder

GUDID B3543430

Needle Holder

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B3543430
• NIH Device Record Key: 144314d6-7350-4668-ad5e-b7b1ac53163b
• Commercial Distribution Discontinuation: 2023-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Needle Holder
• Version Model Number: 343
• 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	B3543430 [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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [Needle Holder]

• B3543430: Needle Holder
• B3543440: Needle Holder