FDA.reportPublic FDA data

SAIKANG

Primary DI
06974539960002
Brand
SAIKANG
Company
Jiangsu Saikang Medical Equipment Co.,Ltd.
Model
SK-L005
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQPLamp, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974539960002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974539960002069745399600026974539960002

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
421298960
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761968547Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
00887761976450Pre-Install Set Helux ProBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761976474Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977334Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977341Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977358Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977365Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977389Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761970939Carbon SectionsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761974432Control UnitsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972902Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972926Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972957Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761968134Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15