FDA.reportPublic FDA data

None

Primary DI
00886874119129
Brand
None
Company
INTUITIVE SURGICAL, INC.
Model
490024
Device description
Reprocessing Accessories Kit
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (flexible or rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182188000Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical2019-02-14EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886874119129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886874119129008868741191298868741191290886874119129

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope cleaning brush, reusableA device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
938647021
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874112120EndoWrist4700012016-07-08
00886874112168EndoWrist4700072016-07-08
00886874112229EndoWrist4700332016-07-08
00886874112236EndoWrist4700362016-07-08
00886874112304EndoWrist4701812016-07-08
00886874112342EndoWrist4701942016-07-08
00886874112366EndoWrist4702072016-07-08
00886874112373EndoWrist4702152016-07-08
00886874112380EndoWrist4702302016-07-08
00886874112397EndoWrist4702462016-07-08
00886874112403EndoWrist4702492016-07-08
00886874112441EndoWrist4703182016-07-08
00886874112465EndoWrist4703272016-07-08
00886874112496EndoWrist4703472016-07-08
00886874112670EndoWrist4704012016-07-08
00886874114384EndoWrist SP4300602018-09-20
00886874110720daVinci Xi3806522016-07-08
00886874116272PlanPoint3807182019-03-21
10886874114343None4300122018-09-20
00886874113509EntryGuide4300222018-09-20

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06972084140641WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28
06972084140658WiScope®Ningbo Wise Optomech Technology CorporationEOQ2026-07-28
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.EOQ2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.EOQ2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.EOQ2026-05-27
04719872715108MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715115MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715122MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715283MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
04719872715290MiiS Horus Endoscope Display SystemMEDIMAGING INTEGRATED SOLUTION INC.EOQ2026-04-29
00856571007265EasyPath RF Introducer SheathBRONCUS MEDICAL INC.EOQ2026-04-23
00850048825093Galaxy System - HKNoah Medical CorporationEOQ2026-04-21
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00886874124871Ion Tomosynthesis BoardINTUITIVE SURGICAL, INC.EOQ2025-11-11
00850048825086Galaxy System (Cart) - RefurbishedNoah Medical CorporationEOQ2025-10-25
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.EOQ2025-08-04
10810068811510Monarch™ Laptop P17 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1Auris Health, Inc.EOQ2025-06-04
04547410513790FUJIFILMFUJIFILM CORPORATIONEOQ2025-05-31
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.EOQ2025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0Auris Health, Inc.EOQ2025-03-03
04961333254989PENTAXHOYA CORPORATIONEOQ2024-07-26
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05