FDA.reportPublic FDA data

MicroAire®

Primary DI
00847399006950
Brand
MicroAire®
Company
Microaire Surgical Instruments LLC
Model
ELEC-220
Device description
POWER CORD, FOR 220V, CONSOLES 1020/1025/7025
Published
2021-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847399006950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847399006950008473990069508473990069500847399006950

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity91 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius49 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
103056420
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
00847399003591MicroAire® 2500-1002022-02-07
00847399003607MicroAire® 2500-2002022-02-07
00847399017406MicroAire®CART-CLAMP2025-08-01
00847399017413MicroAire® 70202025-08-01
00847399017420MicroAire® 7020-PAL2025-08-01
00847399017437MicroAire®5020-ASP2025-08-01
00847399017444MicroAire®7020-ASP2025-08-01
00847399017451MicroAire®7020-INF2025-08-01
00847399017468MicroAire®7020-PEDAL2025-08-01
00847399017475MicroAire® ASP-PUMP-1202025-08-01
00847399017482MicroAire® ASP-UI2025-08-01
00847399017499MicroAire® ASP-CBL2025-08-01
00847399017505MicroAire®ASP-FOOT2025-08-01
00847399017512MicroAire®ASP-FLTR22025-08-01
00847399017536MicroAire®CART2025-08-01
00847399017543MicroAire®CART-RING2025-08-01
00847399017550MicroAire®CART-IV-POLE2025-08-01
00847399018960MicroAire®ASP-TUBING2025-08-01
00847399019004MicroAire®CART-POLE2025-08-01
00847399019011MicroAire®CART-BASKET2025-08-01

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Primary DI, Brand, Company table
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07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
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08800038040441Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
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