Single-Site; daVinci Si

GUDID 00886874111956

FUNDUS GRASPER

INTUITIVE SURGICAL, INC.

Flexible endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00886874111956
• NIH Device Record Key: 0a3912ce-216e-4e86-a056-793ed1957871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Site; daVinci Si
• Version Model Number: 428058
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874111956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122532

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

[00886874111956]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-02
• Device Publish Date: 2016-07-08

On-Brand Devices [Single-Site; daVinci Si]

• 00886874113479: DOCK ASSIST TOOL
• 00886874112113: WRISTED NEEDLE DRIVER
• 10886874112103: FENESTRATED BIPOLAR FORCEPS
• 00886874112090: PERMANENT CAUTERY HOOK
• 00886874112083: CURVED NEEDLE DRIVER
• 00886874111963: CROCODILE GRASPER
• 00886874111956: FUNDUS GRASPER
• 00886874111949: CURVED SCISSORS
• 00886874111925: CADIERE FORCEPS
• 00886874111918: SUCTION IRRIGATOR
• 00886874111901: CLIP APPLIER, HEM-O-LOK ML
• 00886874111895: MONOPOLAR CAUTERY
• 00886874111888: MARYLAND DISSECTOR