SIREN SGT SGT-36

GUDID 00860002701363

Suction-regulated orogastric calibration tube, 36 Fr

TOOLS FOR SURGERY, LLC

Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube Nasogastric/orogastric tube

• Primary Device ID: 00860002701363
• NIH Device Record Key: f9a09409-0605-4bab-9acf-f2a634daeb72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIREN SGT
• Version Model Number: SGT-36
• Catalog Number: SGT-36
• Company DUNS: 841842441
• Company Name: TOOLS FOR SURGERY, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002701363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220218

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17

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