FDA.reportPublic FDA data

Radiance

Primary DI
00818089020938
Brand
Radiance
Company
Nds Surgical Imaging LLC
Model
90X0602
Device description
"RADIANCE G2 42"", W/ SINGLE FIBER, LC CONN, CUSTOM KARL STORZ GMBH, SC-WU42-A1515"
Published
2022-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818089020938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818089020938008180890209388180890209380818089020938

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081712583
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818089022437Radiance90R01302026-02-10
00818089023007Radiance 90Z03032022-10-15
00818089023014Radiance 90Z03042022-10-15
00818089022659ZeroWire G2 90Z1782022-08-11
00818089022697ZeroWire G2 90Z01632022-08-11
00818089022703ZeroWire G2 90Z01542022-08-11
00818089022840ZeroWire G2 90Z01802022-08-11
00818089022857ZeroWire G2 90Z01972022-08-11
00818089022864ZeroWire G2 90Z01992022-08-11
00818089020952Radiance 90X06062022-08-05
00818089020969Radiance 90X06122022-08-05
00818089021096Radiance 90X06562022-08-05
00818089021553Radiance 90X05992022-08-05
00818089021577Radiance 90X066592022-08-05
00818089022680ZeroWire G2 90X06122022-08-05
00818089022819ZeroWire G2 90T21132022-08-01
00818089022826ZeroWire G2 90T21142022-08-01
00818089022741ZeroWire 90T21072021-09-27
00818089022758ZeroWire 90T21082021-09-27
00818089022765ZeroWire 90T21092021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
10195594671501CARDINAL HEALTHCardinal Health 200, LLCKQM2022-05-31
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
10195594436452CARDINAL HEALTHCardinal Health 200, LLCKQM2021-12-02
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
08800025400159Dr.s cam VGOOD DOCTORS CO., LTD.KQM2020-01-16
08800025400173EZ SHOT HD VGOOD DOCTORS CO., LTD.KQM2020-01-16
08800025400296Charger_DLGOOD DOCTORS CO., LTD.KQM2019-11-26
08800025400234Disposable cover_35x100_wideGOOD DOCTORS CO., LTD.KQM2019-11-22
08800025400241Disposable cover_60x200_wideGOOD DOCTORS CO., LTD.KQM2019-11-22
08800025400258Disposable cover_35x100_narrowGOOD DOCTORS CO., LTD.KQM2019-11-22
08800025400265Disposable cover_46x195_wide/100 pcsGOOD DOCTORS CO., LTD.KQM2019-11-22
08800025400289Disposable cover_60x280_narrowGOOD DOCTORS CO., LTD.KQM2019-11-22
08800025400012Whicam Story3_wirelessGOOD DOCTORS CO., LTD.KQM2019-10-30
08800025400029Whicam Story3_wiredGOOD DOCTORS CO., LTD.KQM2019-10-30
08800025400036Dr's Cam_wirelessGOOD DOCTORS CO., LTD.KQM2019-10-30
08800025400043Dr's Cam_wiredGOOD DOCTORS CO., LTD.KQM2019-10-30