FDA.reportPublic FDA data

Single-Use Ureterorenoscope

Primary DI
06970462546467
Brand
Single-Use Ureterorenoscope
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
HU30M
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240374000Ureterorenoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-05-10FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970462546464PackageGS11Not in Commercial Distribution
26970462546461PackageGS110Not in Commercial Distribution
36970462546468PackageGS15Not in Commercial Distribution
06970462546467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254646416970462546464
2697046254646126970462546461
3697046254646836970462546468
06970462546467069704625464676970462546467

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureterorenoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device.

Regulatory Flags#

DUNS number
403655303
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979988682000Single-Use UreterorenoscopeHU30S-V2026-07-25
06979988682017Single-Use UreterorenoscopeHU30M-V2026-07-25
06979988682024Single-Use UreterorenoscopeHU30SC-V2026-07-25
06979988682031Single-Use UreterorenoscopeHU30SC2026-07-25
06970462547334HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/082026-07-11
06970462547341HueRex™ Disposable Stone Retrieval BasketBS-3P-5312/112026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/082026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketBS-3P-0612/112026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/082026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketBS-3P-0712/112026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/102026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketBS-4P-0612/162026-07-11
06970462546771Single-use Ureteral Access SheathY-10-502025-07-23
06970462546788Single-use Ureteral Access SheathY-11-402025-07-23
06970462546795Single-use Ureteral Access SheathY-11-502025-07-23
06970462546801Single-use Ureteral Access SheathY-12-402025-07-23
06970462546818Single-use Ureteral Access SheathY-12-502025-07-23
06970462547457Single-use Ureteral Access SheathY-08-362026-02-10
06970462547464Single-use Ureteral Access SheathY-08-402026-02-10
06970462547471Single-use Ureteral Access SheathY-08-452026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140535WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140559WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140757WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140764WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140771WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140788WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140795AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140801AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06979988682000Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25
06979988682017Single-Use UreterorenoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.FGB2026-07-25