FDA.reportPublic FDA data

SafeLight

Primary DI
07613327462777
Brand
SafeLight
Company
STRYKER CORPORATION
Model
0233050400
Catalog number
0233050400
Device description
Fiber Optic Cable with Advanced Imaging Modality
Published
2020-09-04
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
OWNConfocal optical imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192292000L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker2019-11-19OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327462777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327462777076133274627777613327462777

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
Length3.05Meter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403001ActivSight Light EngineActiv Surgical, Inc.OWN2026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403025ActivSIght Light GuideActiv Surgical, Inc.OWN2026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949799Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949805Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949812Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949829Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949836Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949843Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949850Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949867Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949874Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949881Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949898Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949904Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949911Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949928Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949935Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
04048551418123n.a.Karl Storz GmbH & Co. KGOWN2025-08-11
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17