Quest Laparoscope ART-LAP-0006

GUDID 08719324487016

Quest Projects B.V.

Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope Rigid optical laparoscope
Primary Device ID08719324487016
NIH Device Record Key3f30ae2d-4a68-419a-b3da-ee1859fb1b37
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuest Laparoscope
Version Model NumberART-LAP-0006
Catalog NumberART-LAP-0006
Company DUNS386614502
Company NameQuest Projects B.V.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108719324487016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


[08719324487016]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-23
Device Publish Date2016-09-14

On-Brand Devices [Quest Laparoscope]

08719324487023ART-LAP-0007
08719324487016ART-LAP-0006

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