FDA.reportPublic FDA data

VISION LED

Primary DI
01815871021647
Brand
VISION LED
Company
D.R.E., INC.
Model
DRE 061512
Device description
DRE Vision LED, WALL MOUNT
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
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01815871021647PackageGS11In Commercial Distribution
00815871021647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01815871021647018158710216471815871021647
00815871021647008158710216478158710216470815871021647

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light standA mobile device 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]. It is a mobile floor stand with wheels, and may include articulated arms to enable dynamic positioning; the device to be supported (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
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
01815871021739VISION EX5DRE 0614132016-09-23
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
00816744020118NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021139NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021313NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021337NICO MyriadNICO CORPORATIONFST2025-07-30
00816835024353Vu160Medical Illumination International Inc.FST2025-02-19
01816835024369Vu160Medical Illumination International Inc.FST2025-02-19
00816744020095NICO MyriadNICO CORPORATIONFST2024-11-13
00816744020101NICO MyriadNICO CORPORATIONFST2024-11-13
01816835024345SM1Medical Illumination International Inc.FST2024-09-04
01816835024321MI-1000CAMMedical Illumination International Inc.FST2024-08-19
01816835024338MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00840606184922Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00840606184946Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
01816835024314SYSTEM TWO LEDMedical Illumination International Inc.FST2024-01-18
01816835024307SYSTEM TWO LEDMedical Illumination International Inc.FST2024-01-02
00195377048752NuVasiveNuvasive, Inc.FST2023-11-16
01816835024000IsoLED II LED HL (AC)Medical Illumination International Inc.FST2023-10-02
0081683502407090 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
0181683502408690 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
0181683502409390 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
0181683502410990 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
01816835024116105 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
01816835024123105 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
01816835024130105 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
01816835024147105 Deg Fiber Optic HLMedical Illumination International Inc.FST2023-10-02
00888867353244Arthrex®ARTHREX, INC.FST2023-08-11
01816835023898Vu-EMedical Illumination International Inc.FST2022-12-09
B382SD32000Surgical DirectSurgical Direct, Inc.FST2022-11-23
00816835023783SYSTEM TWO LEDMedical Illumination International Inc.FST2022-10-12
00816835023776VistOR MS LEDMedical Illumination International Inc.FST2022-10-07