FDA.reportPublic FDA data

LEWIN

Primary DI
06976041611021
Brand
LEWIN
Company
Shandong Lewin Medical Equipment Co., Ltd.
Model
CreLed 5700
Published
2023-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976041611021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976041611021069760416110216976041611021

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
546175601
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976041611014LEWINCreLed 5700/55002023-02-09
06976041611038LEWINCreLed 55002023-02-09
06976041611045LEWINCreLed 3400/33002023-02-09
06976041611052LEWINCreLed 34002023-02-09
06976041611076LEWINHollow CreLed 5700/55002023-02-09
06976041611083LEWINHollow CreLed 57002023-02-09
06976041611090LEWINHollow CreLed 55002023-02-09
06976041611106LEWINCreLed 5500M2023-02-09
06976041611113LEWINCreLed 3300M2023-02-09
06976041611120LEWINHollow CreLed 5500M2023-02-09
06976041611137LEWINCreLed 310M2023-02-09
06976041611144LEWINCreLed 150M2023-02-09
06976041612011LEWINCreBle 10002023-02-09
06976041612028LEWINCreBle 20002023-02-09
06976041612035LEWINCreBle 30002023-02-09
06976041612042LEWINCreBle 2002023-02-09
06976041612059LEWINCreBle 15002023-02-09
06976041612066LEWINCreBle 21002023-02-09
06976041613018LEWINCreLife 1002023-02-09
06976041613025LEWINCreLife 20002023-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436193VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20