FDA.reportPublic FDA data

VISION LED

Primary DI
01815871021654
Brand
VISION LED
Company
D.R.E., INC.
Model
DRE 061513
Device description
DRE Vision LED, 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
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
01815871021654PackageGS11In Commercial Distribution
00815871021654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01815871021654018158710216541815871021654
00815871021654008158710216548158710216540815871021654

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
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
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00816835024391SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024407SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024414SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024421SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024438SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024445SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024452SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024469SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024476SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
00816835024483SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
10845854040379CONMEDConmed CorporationFST2026-03-24
00816744020118NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021139NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021313NICO MyriadNICO CORPORATIONFST2025-07-30
00816744021337NICO MyriadNICO CORPORATIONFST2025-07-30
00816835024360Vu160Medical Illumination International Inc.FST2025-02-19
00816835024353Vu160Medical Illumination International Inc.FST2025-02-19
01816835024369Vu160Medical Illumination International Inc.FST2025-02-19
00816744020095NICO MyriadNICO CORPORATIONFST2024-11-13
00816744020101NICO MyriadNICO CORPORATIONFST2024-11-13
00816835024346SM1Medical Illumination International Inc.FST2024-09-04
01816835024345SM1Medical Illumination International Inc.FST2024-09-04
00816835024322MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00816835024339MI-1000CAMMedical Illumination International Inc.FST2024-08-19
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
00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07