FDA.reportPublic FDA data

Volista

Primary DI
03700712436193
Brand
Volista
Company
MAQUET SAS
Model
ARDVCS209065A
Device description
VCSII64DF CV SB0810
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSYLight, surgical, ceiling mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130513000VOLISTA 400; VOLISTA 600Maquet S.A.S.2013-05-08FTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700712436193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700712436193037007124361933700712436193

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
264700139
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700712436124VolistaARDVCS209058A2026-07-20
03700712436131VolistaARDVCS209059A2026-07-20
03700712436148VolistaARDVCS209060A2026-07-20
03700712436155VolistaARDVCS209061A2026-07-20
03700712436162VolistaARDVCS209062A2026-07-20
03700712436179VolistaARDVCS209063A2026-07-20
03700712436186VolistaARDVCS209064A2026-07-20
03700712436209VolistaARDVCS209066A2026-07-20
03700712436216VolistaARDVCS209067A2026-07-20
03700712436223VolistaARDVCS209068A2026-07-20
03700712436230VolistaARDVCS209069A2026-07-20
03700712436247VolistaARDVCS209070A2026-07-20
03700712436254VolistaARDVCS209071A2026-07-20
03700712436261VolistaARDVCS209072A2026-07-20
03700712436278VolistaARDVCS209073A2026-07-20
03700712436285VolistaARDVCS209074A2026-07-20
03700712436292VolistaARDVCS209075A2026-07-20
03700712436308VolistaARDVCS209076A2026-07-20
03700712436315VolistaARDVCS209077A2026-07-20
03700712436322VolistaARDVCS209078A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20
03700712436360VolistaMAQUET SASFSY2026-07-20