FDA.reportPublic FDA data

Meicen

Primary DI
06977071930014
Brand
Meicen
Company
Guangdong Meicen Medical Equipment Co., Ltd.
Model
/
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWYHolder, Head, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977071930014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071930014069770719300146977071930014

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724689169
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977071936009Meicen/2024-06-21
06977071930069Meicen/2024-06-21
06977071930908Meicen/2024-06-21
06977071937501Meicen/2024-06-21
06977071937518Meicen/2024-06-21
06977071938003Meicen/2024-06-21
06977071938102Meicen/2024-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640178061811pearltecPearl Technology AGIWY2025-07-28
04719879740615Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741179Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741186Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741193Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741209Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741216Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741223Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741230Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741247Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741162Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-11
04719879741285Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-10
04719879741261Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741278Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741292Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741308Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741315Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741322Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
00810004900622Neocis Guidance SystemNEOCIS INCIWY2025-05-02
00850043319146Head StabilizerHyperfine Operations, Inc.IWY2024-12-11
00810050245531NADOMICO MED-DEVICE, LLCIWY2024-06-21
06977071930069MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
00810050245487NADOMICO MED-DEVICE, LLCIWY2023-05-01
G242RHIAB9Techno-AideTechno-Aide, Inc.IWY2023-02-13
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.IWY2023-01-25
00840326416037PanoramicYoung Innovations, Inc.IWY2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761968424TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGIWY2023-01-05