FDA.reportPublic FDA data

Flexision

Primary DI
00886874115954
Brand
Flexision
Company
INTUITIVE SURGICAL, INC.
Model
490102
Device description
Biopsy Needle, 23G
Published
2019-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886874115951PackageGS15In Commercial Distribution
00886874115954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088687411595110886874115951
00886874115954008868741159548868741159540886874115954

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Regulatory Flags#

DUNS number
938647021
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886874116241Ion3807072019-03-21
00886874112342EndoWrist4701942016-07-08
00886874116234Ion3807482019-03-21
00886874110898daVinci Xi3811212016-07-08
00886874110720daVinci Xi3806522016-07-08
00886874110744daVinci Xi3806772016-07-08
00886874112298EndoWrist4701792016-07-08
00886874115374da Vinci Xi3807232017-11-01
00886874115404daVinci X3806202017-06-06
00886874112366EndoWrist4702072016-07-08
00886874112120EndoWrist4700012016-07-08
00886874112168EndoWrist4700072016-07-08
00886874112229EndoWrist4700332016-07-08
00886874112236EndoWrist4700362016-07-08
00886874112304EndoWrist4701812016-07-08
00886874125663Force Feedback4773092026-03-26
00886874115732None4700422019-08-26
00886874112786None9510212016-07-08
00886874112793None9510262016-07-08
00886874115602None3130352017-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
04547410520583FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
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
04547410520545FUJIFILMFUJIFILM CORPORATIONEOQ2024-05-15
10810068810834Bronchoscope Fluidics TubingAuris Health, Inc.EOQ2024-05-05
10810068810865Monarch BronchoscopeAuris Health, Inc.EOQ2024-05-05
10810068810872Bronchoscope Sheath ValveAuris Health, Inc.EOQ2024-05-05
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
04048551446690N/AKarl Storz GmbH & Co. KGEOQ2023-08-14
10818634025118AmbuBosma EnterprisesEOQ2023-05-01
10818634025132AmbuBosma EnterprisesEOQ2023-05-01
10818634025156AmbuBosma EnterprisesEOQ2023-05-01
10818634025163AmbuBosma EnterprisesEOQ2023-05-01