Single-Use Rhinolaryngoscope

GUDID 16970462546389

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video otorhinolaryngoscope, single-use
Primary Device ID16970462546389
NIH Device Record Key1844f2f4-eba7-4b78-b8e7-e499bcc303a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-Use Rhinolaryngoscope
Version Model NumberRH-M50
Company DUNS403655303
Company NameShenzhen HugeMed Medical Technical Development Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970462546382 [Primary]
GS116970462546389 [Package]
Contains: 06970462546382
Package: CASE [10 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution
GS126970462546386 [Package]
Contains: 06970462546382
Package: CASE [5 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-19
Device Publish Date2024-06-11

On-Brand Devices [Single-Use Rhinolaryngoscope]

16970462546488RH-M32A
16970462546440RH-M40H
16970462546433RH-M52H
16970462546426RH-M58H
16970462546419RH-M22
16970462546402RH-M32
16970462546396RH-M40
16970462546389RH-M50
16970462546372RH-M52
16970462546365RH-M58

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