Single-Use Cystoscope

GUDID 16970462546235

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video cystoscope, single-use
Primary Device ID16970462546235
NIH Device Record Keyca00f2c5-6557-4bb7-81a9-2cfb88d9ae5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-Use Cystoscope
Version Model NumberCY-M52
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
GS106970462546238 [Primary]
GS116970462546235 [Package]
Contains: 06970462546238
Package: CASE [10 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution
GS126970462546232 [Package]
Contains: 06970462546238
Package: CASE [5 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope 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 Cystoscope]

16970462546280CY-M40H
16970462546273CY-M52H
16970462546266CY-M32
16970462546259CY-M40
16970462546242CY-M50
16970462546235CY-M52

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