FDA.report

HarmonyAIR

Primary DI
00724995175702
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
E-Series
Catalog number
LEH13NC02
Device description
E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
Published
2019-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSYLight, surgical, ceiling mounted

Product Code Classifications

CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995175702PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
036985604
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13
00724995222086NATable ExtensionBF002662026-02-13
00724995222093NATable ExtensionBF002672026-02-13
00724995222109NATable ExtensionBF002682026-02-13
00724995244972NATAB800KTLBF7942026-02-13
00724995246891NATable Pad S00XWBF7682026-02-13
00724995246907NATable Pad S20CV3BF7692026-02-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.FSY2026-03-24
20192253051985DevonCardinal Health 200, LLCFSY2026-03-11
00850053798016APEX LEDBurton Medical, LLCFSY2026-02-19
00684706009682iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009699iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009705iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009712iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009729iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009736iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009743iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009750iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009767iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009774iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009781iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009798iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009811iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009828iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00724995243593ALYONSTERIS CORPORATIONFSY2026-01-05
00684706009675iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-25
00684706009644iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009651iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009668iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009330iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009347iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009361iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009378iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009385iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009392iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009408iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
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