FDA.reportPublic FDA data

Lucent Lateral

Primary DI
00840606184922
Brand
Lucent Lateral
Company
SPINAL ELEMENTS, INC.
Model
89100-002
Device description
Dimension Light Cable
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840606184922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606184922008406061849228406061849220840606184922

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816835024384SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
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
00840606184946Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07
00816835024315SYSTEM TWO LEDMedical Illumination International Inc.FST2024-01-18