Ion

GUDID 10886874119591

None

INTUITIVE SURGICAL, INC.

Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile Instrument management bag, sterile

• Primary Device ID: 10886874119591
• NIH Device Record Key: 1575231b-193a-4d95-b5f5-5bc5840d1381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion
• Version Model Number: 490127
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
GS1	00886874119594 [Primary]
GS1	10886874119591 [Package]; Contains: 00886874119594; Package: BOX [10 Units]; In Commercial Distribution
GS1	30886874119595 [Package]; Package: CASE [6 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, surgical, exempt

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [Ion]

• 00886874116241: Controller
• 00886874116234: System Cart
• 10886874116125: Vision Probe
• 00886874116258: Catheter
• 10886874119591: None
• 00886874121184: Vision Probe
• 00886874124796: Catheter