GUDID 03700712414092

EPS 22 OR V2

MAQUET SAS

Operating room light
Primary Device ID03700712414092
NIH Device Record Keyfdfb1565-5cff-4770-80e6-f6c505236e1c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberARD567355969
Company DUNS264700139
Company NameMAQUET SAS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103700712414092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSYLight, surgical, ceiling mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-01-08
Device Publish Date2019-01-21

Devices Manufactured by MAQUET SAS

03700712434540 - Volista2025-06-13 VCSII60SF SAX12
03700712434557 - Volista2025-06-13 VCSII60DF SAX08
03700712434564 - Volista2025-06-13 VCSII66SF SAX1012
03700712434571 - Volista2025-06-13 VCSII66DF SAX0810
03700712434588 - Volista2025-06-13 VCSII40SF SAX12
03700712434595 - Volista2025-06-13 VCSII40DF SAX08
03700712434601 - Volista2025-06-13 VCSII44SF SAX1012
03700712434618 - Volista2025-06-13 VCSII44DF SAX0810

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