FDA.reportPublic FDA data

FocESS

Primary DI
00857326005567
Brand
FocESS
Company
STRYKER CORPORATION
Model
WCS
Catalog number
WCS-100
Device description
HD Wireless Camera
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FWLCamera, Cine, Endoscopic, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWLCamera, Cine, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005564PackageGS11In Commercial Distribution
00857326005567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600556410857326005564
00857326005567008573260055678573260055670857326005567

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024195028MOLLIMM10002021-08-27
00850024195134MOLLIMS-00009MM10122022-06-27
00850024195219MOLLIMP2015A2024-04-13
00850024195141MOLLIMP20012023-03-30
00850024195158MOLLIMT20012023-03-30
00850024195004MOLLIMP10012021-08-27
00850024195011MOLLIMT10012021-08-27
07613327651232SportSuite0203-10000203-10002026-08-21
07613327679410Mini-PRO Pediatric Restraint System (with Modified X-Restraints)6410055500016410055500012026-08-21
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319758977Hayden MedicalHayden Medical, Inc.FWL2026-04-23
08908025548083UnivLabs UNIVLABS TECHNOLOGIES PRIVATE LIMITEDFWL2025-07-01
00840319757963Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757970Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757321Hayden MedicalHayden Medical, Inc.FWL2024-06-27
08800033200048ITS Model-L6KInTheSmart Co., Ltd.FWL2022-11-11
00078301211227Health SupportCarolon CompanyFWL2022-10-18
00851289007224Firefly Firefly GlobalFWL2022-09-20
00860006918705ProsidioProsidio LLCFWL2021-06-06
00863333000327DUROSCOPEFMD, LLCFWL2019-02-09
00863333000334DUROSCOPEFMD, LLCFWL2019-02-09
00863333000358DUROSCOPEFMD, LLCFWL2019-02-09
86333300030188DUROSCOPEFMD, LLCFWL2019-02-09
86333300030218DUROSCOPEFMD, LLCFWL2019-02-09
86333300030232DUROSCOPEFMD, LLCFWL2019-02-09
B1778020RF0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-10-18
B1778007I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778008I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778009I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778013I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778019I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778020I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780500Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780520Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
00851289007040RedfinFirefly GlobalFWL2018-08-14
00851289007057FireflyFirefly GlobalFWL2018-08-14
08800033200031ITS Model-LInTheSmart Co., Ltd.FWL2018-06-15
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16