FDA.reportPublic FDA data

Endoso

Primary DI
06975202770195
Brand
Endoso
Company
Hunan Endoso Life Technology Co., Ltd
Model
BC28-3
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231107000Bronchoscope SystemHunan Endoso Life Technology Co., Ltd.2024-02-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975202770195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975202770195069752027701956975202770195

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
722930494
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975202770287EndosoP1-A2025-11-28
06975202770294EndosoP1-B2025-11-28
06975202770300EndosoP1-C2025-11-28
06975202770317EndosoP1-D2025-11-28
06975202770478EndosoP1-E2025-11-28
06975202770485EndosoP2-A2025-11-28
06975202770492EndosoP2-B2025-11-28
06975202770508EndosoP2-C2025-11-28
06975202770515EndosoP2-D2025-11-28
06975202770522EndosoP2-E2025-11-28
06975202772878EndosoPUR12-S2025-11-28
06975202772908EndosoPUR12-42025-11-28
06975202772915EndosoPUR12-52025-11-28
06975202772922EndosoPUR12-62025-11-28
06975202772939EndosoPUR12-S12025-11-28
06975202772946EndosoPUR12-S22025-11-28
06975202773059EndosoPUR12-12025-11-28
06975202773073EndosoPUR12-32025-11-28
06975202773066EndosoPUR12-22025-11-26
06975202770102EndosoBC12-12024-07-12

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Primary DI, Brand, Company table
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