FDA.report

Maquet PowerLED II

Primary DI
03700712417529
Brand
Maquet PowerLED II
Company
MAQUET SAS
Model
ARDPWT259006A
Device description
PWDII50SF VP AIM CL XHD127 K3 1116
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FTDLamp, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700712417529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700712417529037007124175293700712417529

GMDN Terms

TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
264700139
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

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03700712434588VolistaARDVCS629004A2025-06-05
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03700712434618VolistaARDVCS629007A2025-06-05
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03700712434632VolistaARDVCS629009A2025-06-05
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03700712434663VolistaARDVCS629073A2025-06-05
03700712434670VolistaARDVCS629074A2025-06-05
03700712434687VolistaARDVCS629077A2025-06-05
03700712434694VolistaARDVCS629078A2025-06-05

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