FDA.reportPublic FDA data

Maisilide

Primary DI
06976696812408
Brand
Maisilide
Company
Shandong Deman Medical Equipment Group Co., Ltd.
Model
YDE700/500
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976696812408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976696812408069766968124086976696812408

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
703425813
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976696810404MaisilideDHC-I2023-11-06
06976696810411MaisilideDHC-II2023-11-06
06976696810428MaisilideDHC-III2023-11-06
06976696810435MaisilideDHC-IV2023-11-06
06976696810442MaisilideDHC-V2023-11-06
06976696810459MaisilideDHC-VI2023-11-06
06976696811401MaisilideDST- 1A2023-11-06
06976696811418MaisilideDST- 22023-11-06
06976696811425MaisilideDST-32023-11-06
06976696811432MaisilideDST- 30032023-11-06
06976696811449MaisilideDST- 30042023-11-06
06976696811456MaisilideDST- 52023-11-06
06976696811463MaisilideDST- 500A2023-11-06
06976696811470MaisilideDST- 7002023-11-06
06976696811487MaisilideDST- 700G2023-11-06
06976696811494MaisilideJR-90002023-11-06
06976696812415MaisilideYDE700/7002023-11-06
06976696812422MaisilideYDE500/5002023-11-06
06976696812439MaisilideYDE7002023-11-06
06976696812446MaisilideYDE5002023-11-06

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Primary DI, Brand, Company table
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