FDA.reportPublic FDA data

VISION EX5

Primary DI
01815871021739
Brand
VISION EX5
Company
D.R.E., INC.
Model
DRE 061413
Device description
DRE Vision EX5, FLOOR MODEL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01815871021739PackageGS11In Commercial Distribution
00815871021739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01815871021739018158710217391815871021739
00815871021739008158710217398158710217390815871021739

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
178440426
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
false
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
0181587102157MAXX LUXX LEDDRE SD2D2P42016-09-23
01815871021586MAXX LUXX LEDDRE SD2D2M12016-09-23
01815871021593MAXX LUXX LEDDRE SD2D2VR2016-09-23
01815871021609MAXX LUXX LEDDRE SD2D2D22016-09-23
01815871021616MAXX LUXX LEDDRE SD2M1M12016-09-23
01815871021623MAXX LUXX LEDDRE SD2SD2P3M12016-09-16
01815871021630MAXX LUXX LEDDRE SD2D2P4M12016-09-23
01815871021647VISION LEDDRE 0615122016-09-23
01815871021654VISION LEDDRE 0615132016-09-23
01815871021685VISION LEDDRE 061512-V2016-09-23
01815871021692VISION LEDDRE 061513-V2016-09-23
01815871021708VISION LEDDRE 061514-V2016-09-23
01815871021715VISION LEDDRE 061515-V2016-09-23
01815871021722VISION EX5DRE 0614122016-09-23
01815871021746VISION EX5DRE 0614142016-09-23
01815871021753VISION EX5DRE 0614152016-09-23
01815871021760VISION EX5DRE 061412-V2016-09-23
01815871021777VISION EX5DRE 061413-V2016-09-23
01815871021784VISION EX5DRE 061414-V2016-09-23
01815871021791VISION EX5DRE 061415-V2016-09-23

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
03700712436193VolistaMAQUET 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