FDA.reportPublic FDA data

Lucent

Primary DI
00840606114936
Brand
Lucent
Company
SPINAL ELEMENTS, INC.
Model
81101-001
Device description
Bifurcated Fiber Optic Clip On Cable, Flat
Published
2019-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840606114936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606114936008406061149368406061149360840606114936

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606174800Primus66440-0002026-03-06
00840606187138Primus66900-0002026-02-27
00840606187145Primus66900-000-012026-02-27
00840606187152Primus66900-000-022026-02-27
00840606187169Primus66900-000-032026-02-27
00840606187176Primus66900-000-042026-02-27
00840606187268Primus66900-0302026-02-27
00840606187275Primus66900-030-012026-02-27
00840606187282Primus66900-030-022026-02-27
00840606187299Primus66900-030-032026-02-27
00840606187305Primus66900-030-042026-02-27
00840606187312Primus66900-030-052026-02-27
00840606187329Primus66900-030-062026-02-27
00840606187336Primus66900-030-072026-02-27
00840606187343Primus66900-030-082026-02-27
00840606187367Primus66900-030-092026-02-27
00840606185172Primus66430-0182026-01-23
00840606185189Primus66430-0242026-01-23
00840606185196Primus66430-1182026-01-23
00840606185202Primus66430-1242026-01-23

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