Ion

GUDID 00886874116234

System Cart

INTUITIVE SURGICAL, INC.

Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system
Primary Device ID00886874116234
NIH Device Record Keyca59f464-9c0a-4132-b8ad-ab8dd9621c59
Commercial Distribution StatusIn Commercial Distribution
Brand NameIon
Version Model Number380748
Company DUNS938647021
Company NameINTUITIVE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886874116234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (flexible or rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-02
Device Publish Date2019-03-21

On-Brand Devices [Ion]

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

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