FDA.reportPublic FDA data

FSN

Primary DI
00810000890040
Brand
FSN
Company
FORESEESON CUSTOM DISPLAYS, INC.
Model
WIS4000
Catalog number
WIS4000
Device description
Wireless Imaging System
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000890040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000890040008100008900408100008900400810000890040

GMDN Terms#

Term, Definition table
TermDefinition
Portable computerA portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-300-0540gudid@fsnmed.com

Regulatory Flags#

DUNS number
029368094
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000890675ArthrexWIS4100WIS41002026-05-08
00810000890712FSNFM-E3230D, FM-E3230DG, FM-E3230DNFM-E3230D, FM-E3230DG, FM-E3230DN2025-09-15
00810000890682FSNFS-E2102D, FS-E2102DTFS-E2102D, FS-E2102DT2024-06-26
00810000890699FSNFS-A2702D, FS-A2702DS, FS-A2702DT, FS-A2702DSTFS-A2702D, FS-A2702DS, FS-A2702DT, FS-A2702DST2024-06-26
00810000890705FSNFS-A3202D, FS-A3202DSFS-A3202D, FS-A3202DS2024-06-26
00810000890590FSNFM-F3101D, FM-F3101DGFM-F3101D, FM-F3101DG2024-03-12
00810000890606FSNFM-E2701D, FM-E2701DGFM-E2701D, FM-E2701DG2024-03-12
00810000890613FSNFM-E2701DT, FM-E2701DGTFM-E2701DT, FM-E2701DGT2024-03-12
00810000890620FSNFM-F2701D, FM-F2701DGFM-F2701D, FM-F2701DG2024-03-12
00810000890231FSNFM-C5501DVFM-C5501DV2022-08-19
00810000890262FSNFM-D5801DVFM-D5801DV2022-08-19
00810000890330FSNFM-D5802DVFM-D5802DV2022-08-19
00810000890347FSNFM-A5504DS, FM-A5504DGFM-A5504DS, FM-A5504DG2022-08-19
00810000890477FSNFM-E3204DGCFM-E3204DGC2022-08-19
00810000890514FSNFM-A5505DGCFM-A5505DGC2022-08-19
00810000890064FSNFS-P3102D, FS-P3102DS, FS-P3102DGFS-P3102D, FS-P3102DS, FS-P3102DG2022-08-02
00810000890156FSNFM-A2701D, FM-A2701DSFM-A2701D, FM-A2701DS2022-08-02
00810000890187FSNFM-B2702D, FM-B2702DGFM-B2702D, FM-B2702DG2022-08-02
00810000890415FSNFM-E3203D, FM-E3203DGFM-E3203D, FM-E3203DG2022-08-02
00810000890118FSNFS-P2603DFS-P2603D2022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819761023117Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
00819761023124Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
04995047074885CuratOREIZO CORPORATIONKQM2026-06-24
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10