Claws Forceps Inner Shaft

GUDID B354382

Claws Forceps Inner Shaft

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354382
• NIH Device Record Key: 4f9c0579-e4e8-45cd-9802-723919c2b792
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Claws Forceps Inner Shaft
• Version Model Number: C382
• 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	B354382 [Unit of Use]
HIBCC	B354C3821 [Primary]
HIBCC	B354C3822 [Primary]
HIBCC	B354C3823 [Primary]
HIBCC	B354C3824 [Primary]
HIBCC	B354C3825 [Primary]
HIBCC	B354C3829 [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

[B354382]

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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 [Claws Forceps Inner Shaft]

• B354C3820: Claws Forceps Inner Shaft
• B354382: Claws Forceps Inner Shaft
• B3543820: Claws Forceps Inner Shaft