Single-Use Ureterorenoscope

GUDID 16970462546457

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video ureterorenoscope, single-use
Primary Device ID16970462546457
NIH Device Record Keya92cdce3-0e82-4346-bcba-17e13f1089e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-Use Ureterorenoscope
Version Model NumberHU30S
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
GS106970462546450 [Primary]
GS116970462546457 [Package]
Contains: 06970462546450
Package: BOX [1 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution
GS126970462546454 [Package]
Package: CASE [10 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution
GS136970462546451 [Package]
Package: CASE [5 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/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 Ureterorenoscope]

16970462546471HU30
16970462546464HU30M
16970462546457HU30S

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