FDA.report

HarmonyAIR

Primary DI
00724995170486
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
G-Series Suspension
Catalog number
LK00013
Device description
The Dual Spindle Light Head 1750mm Light Head 1600mm G-Series 11008907 is used with the HarmonyAIR G-Series Suspension System.
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995170486PrimaryGS10

GMDN Terms

TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
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
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
04061591001032MultibarOndal Medical Systems GmbHFQO2026-02-02
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678795ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678801ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678818ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678825ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678832ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
10841736124298Skytron LLCSKYTRON LLCFQO2025-12-09
10841736124861SkytronSKYTRON LLCFQO2025-12-03
10841736125226SkytronSKYTRON LLCFQO2025-12-03
06948350528826MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528833MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528864MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528871MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528888MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528895MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528901MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528918MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528925MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528932MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528949MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528963MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528970MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528987MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528994MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350529007MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22