Allis Grasper Horizontal Teeth Inner Shaft

GUDID B354397

Allis Grasper Horizontal Teeth Inner Shaft

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354397
• NIH Device Record Key: 029745dd-9b90-424b-99cc-b2d040498f15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allis Grasper Horizontal Teeth Inner Shaft
• Version Model Number: C397
• 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	B354397 [Unit of Use]
HIBCC	B354C3971 [Primary]
HIBCC	B354C3972 [Primary]
HIBCC	B354C3973 [Primary]
HIBCC	B354C3974 [Primary]
HIBCC	B354C3975 [Primary]
HIBCC	B354C3979 [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

[B354397]

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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 [Allis Grasper Horizontal Teeth Inner Shaft]

• B354C3970: Allis Grasper Horizontal Teeth Inner Shaft
• B354397: Allis Grasper Horizontal Teeth Inner Shaft
• B3543970: Allis Grasper Horizontal Teeth Inner Shaft