EndoWrist SP

GUDID 00886874123478

NEEDLE DRIVER

INTUITIVE SURGICAL, INC.

Robotic surgical needle holder, reusable

• Primary Device ID: 00886874123478
• NIH Device Record Key: b9d51468-66ba-4772-ac8a-a9a6c4fc14f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoWrist SP
• Version Model Number: 430200
• 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: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874123478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241814

FDA Product Code

• NAY: System, surgical, computer controlled instrument

Sterilization

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

[00886874123478]

Moist Heat or Steam Sterilization

[00886874123478]

Moist Heat or Steam Sterilization

[00886874123478]

Moist Heat or Steam Sterilization

[00886874123478]

Moist Heat or Steam Sterilization

[00886874123478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [EndoWrist SP]

• 00886874115213: CADIERE FORCEPS
• 00886874115190: ROUND TOOTH RETRACTOR
• 00886874114384: CAMERA, 0°
• 00886874114339: FENESTRATED BIPOLAR FORCEPS
• 00886874114322: MARYLAND BIPOLAR FORCEPS
• 00886874114315: MONOPOLAR CAUTERY INSTRUMENT
• 00886874114308: NEEDLE DRIVER
• 00886874114292: MEDIUM-LARGE CLIP APPLIER
• 00886874114285: MONOPOLAR CURVED SCISSORS
• 00886874122228: CAMERA, 0°
• 00886874124147: MONOPOLAR CAUTERY INSTRUMENT
• 00886874124130: MEDIUM-LARGE CLIP APPLIER
• 00886874124086: CADIERE FORCEPS ER
• 00886874124079: MARYLAND BIPOLAR FORCEPS ER
• 00886874124062: NEEDLE DRIVER ER
• 00886874124055: FORCE BIPOLAR ER
• 00886874124048: MONOPOLAR CURVED SCISSORS ER
• 00886874124031: ROUND TOOTH RETRACTOR ER
• 00886874123843: CADIERE FORCEPS
• 00886874123478: NEEDLE DRIVER
• 00886874123461: MARYLAND BIPOLAR FORCEPS
• 00886874123454: MONOPOLAR CURVED SCISSORS
• 00886874123447: FENESTRATED BIPOLAR FORCEPS