Baton

GUDID B354300030

Baton

ORANGE SURGICAL INSTRUMENTS, LLC

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: B354300030
• NIH Device Record Key: 20127cbd-27be-4e8c-9e94-a2b79f2fc4fe
• Commercial Distribution Discontinuation: 2023-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Baton
• Version Model Number: 30003
• 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	B354300030 [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

Devices Manufactured by ORANGE SURGICAL INSTRUMENTS, LLC

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• B354OSMCR4MMX5MR0 - 4mm Plug x 5M Monopolar Cable Reusable: 2025-02-18
• B354HAF2LGS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Small: 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Small Heart Assist, Single Use, 2 Finger Long, Malleable, 63mm W x 90mm L
• B354HAF2SHS0 - Stainless Steel Cardiac 2 Finger Heart Retractor - Large: 2025-01-17 Stainless Steel Cardiac 2 Finger Heart Retractor - Large Heart Assist, Sing Use, 2 Finger Short, Malleable 36mm x 54mm
• B354HAF3LGS0 - Stainless Steel Cardiac 3 Finger Heart Retractor - Small: 2025-01-17 Stainless Steel Cardiac 3 Finger Heart Retractor - Small Heart Assist, Single Use, 3 Finger Long, Malleable, 60mm W x 90mm