F88 0228388000

GUDID 08881300750152

Flexible Camera Control Unit

SG ENDOSCOPY PTE. LTD.

Flexible video ureteroscope, reusable
Primary Device ID08881300750152
NIH Device Record Keyee083a25-ec0c-488b-8c3e-e8005859c156
Commercial Distribution StatusIn Commercial Distribution
Brand NameF88
Version Model NumberF88 Flexible Camera Control Unit
Catalog Number0228388000
Company DUNS595455258
Company NameSG ENDOSCOPY PTE. 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108881300750152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


[08881300750152]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-08
Device Publish Date2025-06-30

On-Brand Devices [F88]

08881300750152Flexible Camera Control Unit
08881300750046Pkg, Luer Lock Stopcock, Reusable, Female X Male
08881300750091Flexible Ureteroscope, Reverse Deflection
08881300750084Flexible Ureteroscope, Standard Deflection
08881300750077Pkg, Manual Leak Tester
08881300750060Pkg, Venting Valve Cap With Sterilization Card

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