Single-Use Rhinolaryngoscope

Primary DI
06970462546481
Brand
Single-Use Rhinolaryngoscope
Company
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Model
RH-M32A
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
16970462546488PackageGS11Not in Commercial Distribution
26970462546485PackageGS11Not in Commercial Distribution
06970462546481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697046254648816970462546488
2697046254648526970462546485
06970462546481069704625464816970462546481

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

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Primary DI, Brand, Model table
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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

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