Single-Use Choledochoscope

GUDID 16970462546310

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video choledochoscope, single-use
Primary Device ID16970462546310
NIH Device Record Keyc8c8ac07-7b45-4618-8845-ecce22ab993c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-Use Choledochoscope
Version Model NumberCH-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
GS106970462546313 [Primary]
GS116970462546310 [Package]
Contains: 06970462546313
Package: CASE [10 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution
GS126970462546317 [Package]
Contains: 06970462546313
Package: CASE [5 Units]
Discontinued: 2024-06-11
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBNCholedochoscope 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 Choledochoscope]

16970462546358CH-M52H
16970462546341CH-M40H
16970462546334CH-M32
16970462546327CH-M40
16970462546310CH-M52
16970462546303CH-M50

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