FDA.reportPublic FDA data

CONMED

Primary DI
20845854040420
Brand
CONMED
Company
Conmed Corporation
Model
8054-9
Catalog number
8054-9
Device description
LIGHT GUIDE 4.0MM SCOPE R/A
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864387000
K901035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864387000LUXTEC FIBEROPTIC CABLESLuxtec Corp.1987-05-22EQH
K901035000FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLECuda Products Co.1990-04-23FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854040427Direct MarkingGS10
20845854040420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585404042730845854040427
2084585404042020845854040420

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
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
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776430955MillenniumAvalign Technologies, Inc.EQH2026-09-18
00190776428211MillenniumAvalign Technologies, Inc.EQH2026-08-27
00190776427627MillenniumAvalign Technologies, Inc.EQH2026-08-26
00190776426644MillenniumAvalign Technologies, Inc.EQH2026-08-19
00198506094187ELMED INCORPORATEDELMED INCORPORATEDEQH2026-08-18
04054462900879evonosevonos GmbH & Co. KGEQH2026-08-18
14026704730466PILLINGTELEFLEX INCORPORATEDEQH2026-08-03
00190776422257MillenniumAvalign Technologies, Inc.EQH2026-07-31
14026704921178PILLINGTELEFLEX INCORPORATEDEQH2026-07-30
00198506092879ELMED INCORPORATEDELMED INCORPORATEDEQH2026-07-28
00190776421953MillenniumAvalign Technologies, Inc.EQH2026-07-23
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
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
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
14026704933065PILLINGTELEFLEX INCORPORATEDEQH2025-04-28
14026704933041PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
14026704933058PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
00816835024360Vu160Medical Illumination International Inc.FST2025-02-19