FDA.reportPublic FDA data

Exalt ™

Primary DI
00191506007850
Brand
Exalt ™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00542770
Catalog number
M00542770
Device description
Monitor
Published
2021-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00191506007850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506007850001915060078501915060078500191506007850

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810116024049Dornier MedTech DORNIER MEDTECH AMERICA, INC.EOQ2026-03-24
06937048207884UE DisplayZhejiang UE Medical CorpEOQ2026-02-26
16937048207898UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207904UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
16937048207911UE BRONCHO Single-Use BronchoscopesZhejiang UE Medical CorpEOQ2026-02-26
14547410520580FUJIFILMFUJIFILM CORPORATIONEOQ2026-01-23
00860009430204Recon Steerable SheathSERPEX MEDICAL INC.EOQ2025-12-08
06975202770287EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770294EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770300EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770317EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770478EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770485EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770492EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770508EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770515EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
06975202770522EndosoHunan Endoso Life Technology Co., LtdEOQ2025-11-28
00886874124871Ion Tomosynthesis BoardINTUITIVE SURGICAL, INC.EOQ2025-11-11
00886874126301NoneINTUITIVE SURGICAL, INC.EOQ2025-10-23
10810068811275Extended Patient Introducer MountAuris Health, Inc.EOQ2025-09-04
06975339626624Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626631Mounting HolderMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626642ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626655ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626666ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626673ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626680ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
26975339626697ViewHubMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626709HDMI cableMacroLux Medical Technology Co., Ltd.EOQ2025-08-23
06975339626716Power adapterMacroLux Medical Technology Co., Ltd.EOQ2025-08-23