FDA.reportPublic FDA data

SPOTLIGHT

Primary DI
10705034225173
Brand
SPOTLIGHT
Company
DEPUY SPINE, LLC
Model
292900000
Catalog number
292900000
Device description
Spotlight access system Fiberoptic light guides
Published
2019-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901035000FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLECuda Products Co.1990-04-23FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034225173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503422517310705034225173

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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