None

GUDID 10886874120696

TUBE SET WITH SMOKE EVACUATION

INTUITIVE SURGICAL, INC.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10886874120696
• NIH Device Record Key: 1c3e8f7e-d8ff-4df6-be47-1e09eaafca64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: None
• Version Model Number: 470551
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00886874120699 [Primary]
GS1	10886874120696 [Package]; Contains: 00886874120699; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232610

FDA Product Code

• HIF: Insufflator, laparoscopic

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [None]

• 00886874119334: Scroll Wheel
• 00886874119327: Track Ball
• 00886874119143: Bath Probe
• 00886874119082: Sensor Connection Cleaner
• 00886874116975: Catheter Continuity Cable
• 00886874116852: Continuity Test Stand
• 00886874116845: Reprocessing Cover
• 00886874116630: Leak Test Adapter
• 00886874116289: Catheter Guide
• 10886874116200: Swivel Connector
• 00886874115688: SP CLEANING AND STERILIZATION KIT
• 00886874115602: Light Guide Cable Adapter
• 30886874115146: Arm 4 Proximal Drape
• 10886874114374: MONOPOLAR CURVED SCISSORS (MCS) TIP
• 10886874114350: CAMERA INSTRUMENT SHEATH
• 00886874114155: 3DHD CAMERA HEAD AND CABLE, IKEGAMI HD
• 00886874113516: SP CANNULA, CIRCULAR
• 00886874113493: SP OBTURATOR, CIRCULAR
• 00886874113486: INSTRUMENT ARM DRAPE
• 00886874113462: STERILIZATION TRAY, 8 INSTRUMENTS
• 00886874113455: STERILIZATION TRAY, SINGLE
• 00886874113141: ENDOSCOPE, ALIGNMENT TARGET
• 00886874113103: ENDOSCOPE STERILIZATION TRAY
• 00886874112922: BLADE PROTECTOR
• 00886874112915: CANNULA GAGE PIN
• 00886874112793: CABLE, LIGHT GUIDE
• 00886874112786: BIFURCATED LIGHT GUIDE
• 10886874112738: HARMONIC ACE
• 00886874112663: HASSON CONE
• 00886874112656: HASSON CONE
• 00886874112649: STAPLER BLADELESS OBTURATOR, LONG
• 00886874112632: STAPLER BLADELESS OBTURATOR
• 00886874112625: STAPLER BLUNT OBTURATOR, LONG
• 00886874112618: STAPLER CANNULA, LONG
• 00886874112601: BIPOLAR CAUTERY CORD
• 00886874112595: MONOPOLAR CAUTERY CORD
• 30886874112572: SEAL
• 00886874112564: STAPLER BLUNT OBTURATOR
• 00886874112557: STAPLER CANNULA
• 30886874112541: CANNULA SEAL
• 30886874112510: BLADELESS OBTURATOR, LONG
• 30886874112503: BLADELESS OBTURATOR
• 10886874112479: COLUMN DRAPE
• 00886874112458: CANNULA, FLARED, GROUNDED, REUSABLE
• 00886874112212: ENDOSCOPE
• 00886874112205: ENDOSCOPE
• 30886874112190: ARM DRAPE
• 00886874112182: BLUNT OBTURATOR, LONG
• 00886874112175: BLUNT OBTURATOR
• 00886874112144: CANNULA, LONG, REUSABLE