Ion

GUDID 10886874116125

Vision Probe

INTUITIVE SURGICAL, INC.

Flexible video bronchoscope, single-use
Primary Device ID10886874116125
NIH Device Record Key31df6c87-e411-43e1-b2e2-f3fec667e219
Commercial Distribution StatusIn Commercial Distribution
Brand NameIon
Version Model Number490106
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 Batchtrue
Serial Numberfalse
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
GS100886874116128 [Primary]
GS110886874116125 [Package]
Contains: 00886874116128
Package: BOX [2 Units]
In Commercial Distribution

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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