FDA.reportPublic FDA data

L9000

Primary DI
07613327051339
Brand
L9000
Company
STRYKER CORPORATION
Model
0220210000
Catalog number
0220210000
Device description
LED Light Source
Published
2016-09-23
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
FCWLight source, fiberoptic, routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082813000STRYKER LED LIGHTSOURCEStryker Corp.2008-12-19FCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327051339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327051339076133270513397613327051339

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327632811Maistro06200020000620-002-0002025-10-10
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826927669PENTAX MedicalPENTAX MEDICAL CORPORATIONFCW2026-08-25
04049047788607GimmiGimmi GmbHFCW2026-03-04
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
00855373008029StrykerSUNOPTIC TECHNOLOGIES LLCFCW2025-05-15
04049047788522GimmiGimmi GmbHFCW2025-03-20
04048551366813n.a.Karl Storz GmbH & Co. KGFCW2024-11-28
00840183528577BR Surgical, LLCBR Surgical, LLCFCW2024-10-24
04049197465007RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
04049197465069RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
00840183507763BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
00840183527341BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
04961333071333PENTAXHOYA CORPORATIONFCW2023-07-31
04961333238088PENTAXHOYA CORPORATIONFCW2023-07-31
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFCW2023-03-01
00840319710616Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710623Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710630Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710647Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710654Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710661Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710678Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710685Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710692Hayden MedicalHayden Medical, Inc.FCW2022-07-28
G043MLGA4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGA4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7ST0BEARBear-Ent, LLCFCW2022-05-19