GUDID 03700712400545

TUB SAT 850

MAQUET SAS

Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light
Primary Device ID03700712400545
NIH Device Record Key8e35e81f-e1ab-4470-8e3d-a7447e3d362a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberARD515075899
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
GS103700712400545 [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 Number4
Public Version Date2021-01-08
Device Publish Date2016-09-12

Devices Manufactured by MAQUET SAS

03700712432508 - Maquet Rolite2024-06-28 ROLM EZEA30SF B
03700712432522 - Maquet Rolite2024-06-28 ROLM EZEA30SF TK B
03700712434236 - Maquet PowerLED II2024-06-25 PWDII70SF VP CL K4 SAX14
03700712434243 - Maquet PowerLED II2024-06-25 PWDII50SF CL K4 SAX14
03700712434274 - Maquet PowerLED II2024-06-25 PWDII75DF K4 XO SAX081012
03700712434281 - Maquet PowerLED II2024-06-25 PWDII75DF K3 XO SAX081012
03700712434212 - Maquet PowerLED II2024-03-15 PWDII75DF VP CL K4 SAX1012
03700712434229 - Maquet PowerLED II2024-03-15 PWDII75DF VP4K CL K4 SAX1012
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