FDA.reportPublic FDA data

ATMOS

Primary DI
04250365190816
Brand
ATMOS
Company
ATMOS MedizinTechnik GmbH & Co. KG
Model
S 61 CORIAN® instruments
Published
2024-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETFUnit, Examining/Treatment, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250365190816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250365190816042503651908164250365190816

GMDN Terms#

Term, Definition table
TermDefinition
ENT cabinetA stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319591939
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
04250365195071ATMOSC 051 Thorax2025-03-25
04250365142273ATMOSVariotherm plus2024-11-27
04250365142297ATMOSHygrotherm plus2024-11-27
04250365143065ATMOSVarioair2024-11-27
04250365149791ATMOSC 21 Economy - function column (230 V~)2024-11-27
04250365149807ATMOSC 21 Economy - function column (115 V~)2024-11-27
04250365149814ATMOSC 21 Economy - function column (127 V~)2024-11-27
04250365149821ATMOSC 31 Economy - function column (230 V~)2024-11-27
04250365149838ATMOSC 31 Economy - function column (115 V~)2024-11-27
04250365149845ATMOSC 31 Economy - function column (127 V~)2024-11-27
04250365155471ATMOSHL 21 LED2024-11-27
04250365155488ATMOSHL 21 LED (examination set)2024-11-27
04250365155495ATMOSHL 21 LED (OT set)2024-11-27
04250365155839ATMOSLS 21 LED2024-11-27
04250365155860ATMOSLS 21 LED set, white2024-11-27
04250365156034ATMOSStrobo 21 LED2024-11-27
04250365164084ATMOSS 61 Servant ENT workstation (230 V~)2024-11-27
04250365164107ATMOSS 61 Servant ENT workstation (115 V~)2024-11-27
04250365164114ATMOSS 61 Servant ENT workstation (127 V~)2024-11-27
04250365166187ATMOSS 61 Servant Vision2024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530549BR Surgical, LLCBR Surgical, LLCETF2025-09-05
00840183529918BR Surgical, LLCBR Surgical, LLCETF2025-07-16
04250365149791ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149807ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149814ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149821ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149838ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149845ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164084ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164107ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164114ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365166187ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174960ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174977ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174984ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365175417ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365175677ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190762ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190809ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
00840183528447BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528461BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528300BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528478BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528485BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528386BR Surgical, LLCBR Surgical, LLCETF2024-10-29
00840183528492BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528508BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528515BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183502997BR Surgical, LLCBR Surgical, LLCETF2024-07-23
00840183504229BR Surgical, LLCBR Surgical, LLCETF2024-07-23