FDA.reportPublic FDA data

Single-Use Rhinolaryngoscope

Primary DI
06970462546429
Brand
Single-Use Rhinolaryngoscope
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
RH-M58H
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
EOBNasopharyngoscope (Flexible Or Rigid)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232435000Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.2024-04-26EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970462546426PackageGS110Not in Commercial Distribution
26970462546423PackageGS15Not in Commercial Distribution
06970462546429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254642616970462546426
2697046254642326970462546423
06970462546429069704625464296970462546429

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video otorhinolaryngoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. 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
06970462546719Broncho SamplerBS012026-02-10
06970462546856Stone Collector180ML-L2026-02-10
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
06970462547488Single-use Ureteral Access SheathY-08-502026-02-10
06970462547495Single-use Ureteral Access SheathY-08-552026-02-10
06970462547501Single-use Ureteral Access SheathY-09-362026-02-10
06970462547518Single-use Ureteral Access SheathY-09-452026-02-10
06970462547525Single-use Ureteral Access SheathY-09-552026-02-10
06970462547532Single-use Ureteral Access SheathY-10-362026-02-10
06970462547549Single-use Ureteral Access SheathY-10-452026-02-10
06970462547556Single-use Ureteral Access SheathY-10-552026-02-10
06970462547563Single-use Ureteral Access SheathY-11-362026-02-10
06970462547570Single-use Ureteral Access SheathY-11-452026-02-10
06970462547587Single-use Ureteral Access SheathY-11-552026-02-10
06970462547594Single-use Ureteral Access SheathY-12-362026-02-10
06970462547600Single-use Ureteral Access SheathY-12-452026-02-10
06970462547617Single-use Ureteral Access SheathY-12-552026-02-10
16970462546716Broncho SamplerBS012026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04953170467592DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.EOB2026-04-09
04961333255238VIVIDEOHOYA CORPORATIONEOB2025-12-19
04961333255306VIVIDEOHOYA CORPORATIONEOB2025-12-19
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2024-11-14
00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546368Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546375Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546382Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546399Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546405Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546412Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546436Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546443Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546481Single-Use RhinolaryngoscopeShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
06970462546191Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.EOB2024-06-11
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22