FDA.reportPublic FDA data

LEWIN

Primary DI
06976041613025
Brand
LEWIN
Company
Shandong Lewin Medical Equipment Co., Ltd.
Model
CreLife 2000
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
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976041613025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976041613025069760416130256976041613025

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological operating table, electromechanicalA mobile, electrically-powered motorized table designed to support a patient during gynaecological surgical procedures. The table surface consists of articulated sections that can be elevated, lowered for contouring, or removed to accommodate various anatomical positions; adjustable leg holders/stirrups are also included either directly attached to the table or to its side rails.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546175601
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976041611014LEWINCreLed 5700/55002023-02-09
06976041611021LEWINCreLed 57002023-02-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842430116735ADANTE ADAPTER, MAI CLARK SOCKETMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00842430116766 WELL LEG SUPPORT, SHORTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00840343726720FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726737FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726744FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726751FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726768FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726775FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00842430109294ADANTE SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109300ADANTE EXTENDED SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109317ADANTE TRACTION BOOT, SMALL, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109324ADANTE TRACTION BOOT, LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109331ADANTE TRACTION BOOT, EX LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116605Adante Femoral Hook BracketMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116612Adante Knee Foot SupportMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117008Adante IntelliTouch Hand PendantMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117022Adante Traction Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117039Adante Traction Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117046Adante Pelvic Center BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117053Adante Knee Extension BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117084Adante Knee Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117091Adante Knee Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117107Adante FlexLation Spar, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117114Adante FlexLation Spar, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117121Adante AX Orthopedic Surgical PlatformMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117138Adante Knee Pad Support Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117145Adante Knee Pad Support Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117152Adante Femur LiftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117169Adante Wireless Foot PedalMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117176Adante Supine Perineal PostMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04