Fenestrated Atraumatic Forceps Inner Shaft 43cm

GUDID B3542790

Fenestrated Atraumatic Forceps Inner Shaft 43cm

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B3542790
• NIH Device Record Key: dd72b1a9-8167-496a-8f8d-a09d25172a71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenestrated Atraumatic Forceps Inner Shaft 43cm
• Version Model Number: C279B
• 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	B3542790 [Unit of Use]
HIBCC	B354C2791 [Primary]
HIBCC	B354C2792 [Primary]
HIBCC	B354C2793 [Primary]
HIBCC	B354C2794 [Primary]
HIBCC	B354C2795 [Primary]
HIBCC	B354C2799 [Primary]
HIBCC	B354C279B2 [Primary]
HIBCC	B354C279B3 [Primary]
HIBCC	B354C279B4 [Primary]
HIBCC	B354C279B5 [Primary]
HIBCC	B354C279B9 [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

[B3542790]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Fenestrated Atraumatic Forceps Inner Shaft 43cm]

• B3542790: Fenestrated Atraumatic Forceps Inner Shaft 43cm
• B354C279B0: Fenestrated Atraumatic Forceps Inner Shaft 43cm
• B354279B0: Fenestrated Atraumatic Forceps Inner Shaft 43cm