EntryGuide

GUDID 10886874113506

KIT, C.6.6.6 (STANDARD)

INTUITIVE SURGICAL, INC.

Laparoscopic multi-instrument access port, single-use

• Primary Device ID: 10886874113506
• NIH Device Record Key: 09cb1ac8-7a89-4158-a9db-70716a71b215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EntryGuide
• Version Model Number: 430022
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, INC.
• 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 Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874113509 [Primary]
GS1	10886874113506 [Package]; Contains: 00886874113509; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173906

FDA Product Code

• NAY: System, surgical, computer controlled instrument

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: 2018-10-22
• Device Publish Date: 2018-09-20

Devices Manufactured by INTUITIVE SURGICAL, INC.

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• 00886874123454 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS
• 00886874123461 - EndoWrist SP: 2024-12-17 MARYLAND BIPOLAR FORCEPS
• 00886874123478 - EndoWrist SP: 2024-12-17 NEEDLE DRIVER
• 00886874123843 - EndoWrist SP: 2024-12-17 CADIERE FORCEPS
• 00886874124031 - EndoWrist SP: 2024-12-17 ROUND TOOTH RETRACTOR ER
• 00886874124048 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS ER
• 00886874124055 - EndoWrist SP: 2024-12-17 FORCE BIPOLAR ER