FDA.report

Mobile transformer unit

Primary DI
04046768080263
Brand
Mobile transformer unit
Company
MAQUET GmbH
Model
118081C0
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
04046768080263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046768080263040467680802634046768080263

GMDN Terms

TermDefinition
Isolation transformerA device designed to be used in a mains electricity alternating current (AC) circuit to increase (step-up) or decrease (step-down) voltage, to provide the specified voltage to a parent device; it is not a built-in component of the parent device. It provides isolation between the mains current and the parent device for safety, and has separate primary (input) and secondary (output) coils.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315435859
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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04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768148338Extension plate116033DC2024-11-21
04046768148345Extension plate116033BC2024-11-21
04046768148352Extension plate116033GC2024-11-21
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