FDA.reportPublic FDA data

Zimmer Surgical Light

Primary DI
04061591000578
Brand
Zimmer Surgical Light
Company
Ondal Medical Systems GmbH
Model
Claro
Device description
Light, Surgical, consisting of one or two light heads plus one monitor arm. Lights can be optionally equipped with a camera.
Published
2020-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061591000578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061591000578040615910005784061591000578

GMDN Terms#

Term, Definition table
TermDefinition
Operating 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313485229
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061591000288ValiaBasic2020-08-31
04061591000295ValiaS2020-08-31
04061591001032Multibar040615910010322026-02-02
04061591001292IndependantIDP2025-08-17
04061591001322NuCartNucart2025-03-03
04061591000844MCP Monitor Carrier Program / VALiA Displayw/o CBL2024-06-14
04061591000851MCP Monitor Carrier Program / VALiA Displayw/CBL2024-06-14
04061591000103Acrobat20002020-08-31
04061591000004AcrobatSwing2020-08-31
04061591000028Acrobat20002020-08-31
04061591000042WandbefestigungAcrobat2020-08-31
04061591000066DeckenbefestigungSwing2020-08-31
04061591000073Deckenbefestigung20002020-08-31
04061591000080DeckenbefestigungOSP2020-08-31
04061591000110OndaSpaceOSP2020-08-31
04061591000127ZentralachseZA2020-08-31
04061591000202VersorgungskonsoleM62020-08-31
04061591000240CEMORMonitorträger Anschlusstücke2020-08-31
04061591000257VarioViewVV2020-08-31
04061591000264SpacePortSPO2020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09