FDA.reportPublic FDA data

MaXcess

Primary DI
00887517074973
Brand
MaXcess
Company
Nuvasive, Inc.
Model
1025461
Device description
MaXcess 4 Light Cable, Angled
Published
2019-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K042034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042034000NUVASIVE MAXCESS LIGHT GUIDENuvasive, Inc.2004-10-26FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517074973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517074973008875170749738875170749730887517074973

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(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517729545TLX580126558012652026-04-25
00887517729576TLX580140258014022026-04-25
00887517729620TLX580330558033052026-04-25
00887517729644TLX580340258034022026-04-25
00887517729705TLX581126558112652026-04-25
00887517729767TLX581330558133052026-04-25
00887517729781TLX581340258134022026-04-25
00887517824912TLX179260217926022026-04-25
00887517824929TLX179260317926032026-04-25
00887517824967TLX179260717926072026-04-25
00887517825018TLX179261217926122026-04-25
00887517825025TLX179261317926132026-04-25
00887517825063TLX179261717926172026-04-25
00887517825100TLX179262117926212026-04-25
00887517825124TLX179262317926232026-04-25
00887517825162TLX179262717926272026-04-25
00887517825216TLX179263217926322026-04-25
00887517825261TLX179263717926372026-04-25
00887517825315TLX179264217926422026-04-25
00887517825322TLX179264317926432026-04-25

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Primary DI, Brand, Company table
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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
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00816835024346SM1Medical Illumination International Inc.FST2024-09-04
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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
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00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07