Dolphin Grasper Inner Shaft

GUDID B354331

Dolphin Grasper Inner Shaft

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354331
• NIH Device Record Key: 13f438a9-451c-4cf5-8792-e309e2bd3ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dolphin Grasper Inner Shaft
• Version Model Number: C331
• 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	B354331 [Unit of Use]
HIBCC	B354C3311 [Primary]
HIBCC	B354C3312 [Primary]
HIBCC	B354C3313 [Primary]
HIBCC	B354C3314 [Primary]
HIBCC	B354C3315 [Primary]
HIBCC	B354C3319 [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

[B354331]

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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 [Dolphin Grasper Inner Shaft]

• B3543310: Dolphin Grasper Inner Shaft
• B354C3310: Dolphin Grasper Inner Shaft
• B354331: Dolphin Grasper Inner Shaft