FDA.reportPublic FDA data

Center Focus Handle

Primary DI
10841736100278
Brand
Center Focus Handle
Company
SKYTRON LLC
Model
Sterilizable Center Focus Handle
Catalog number
B1-710-49-C
Device description
Center Focus Handle with Intensity Control for Aurora II, Aurora 3 and Aurora Four Lights
Published
2016-09-19
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
FTALight, surgical, accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841736100275Direct MarkingGS10
10841736100278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084173610027520841736100275
1084173610027810841736100278

GMDN Terms#

Term, Definition table
TermDefinition
Operating room light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736125271Skytron4-040-224-040-222026-05-01
10841736125257Sterling Washers291853329185332026-04-26
10841736124441SkytronSOFPADII1-021-03-22026-04-14
10841736124458SkytronSOFPADII1-021-03-32026-04-14
10841736124465SkytronSOFPADII1-021-03-42026-04-14
10841736124472SkytronSOFPADII1-021-06-22026-04-14
10841736124489SkytronSOFPADII1-021-06-32026-04-14
10841736124496SkytronSOFPADII1-021-06-42026-04-14
10841736124502SkytronSOFPADII1-021-07-22026-04-14
10841736124519SkytronSOFPADII1-021-07-32026-04-14
10841736124526SkytronSOFPADII1-021-07-42026-04-14
10841736124533SkytronSOFPADII1-021-08-22026-04-14
10841736124540SkytronSOFPADII1-021-08-32026-04-14
10841736124557SkytronSOFPADII1-021-08-42026-04-14
10841736124564SkytronSOFPADII1-021-11-22026-04-14
10841736124571SkytronSOFPADII1-021-11-32026-04-14
10841736124588SkytronSOFPADII1-021-11-42026-04-14
10841736124595SkytronSOFPADII1-021-12-22026-04-14
10841736124601SkytronSOFPADII1-021-12-32026-04-14
10841736124618SkytronSOFPADII1-021-12-42026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08
16931918123493B.braunGRI Medical & Electronic Technology Co., Ltd.FTA2021-02-27