FDA.reportPublic FDA data

Meicen

Primary DI
06977071930908
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
IXGPhantom, Anthropomorphic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977071930908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071930908069770719309086977071930908

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
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
06977071930014Meicen/2024-06-21
06977071930069Meicen/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
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030949Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030956Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030963Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030970Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030987Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030994Rando®Providus Holdings, Inc.IXG2024-07-11
00812266031007Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030758LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030765LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030772LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030789LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030796LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030802LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030697LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030703LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030710LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030727LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030734LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030741LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
09355529000033T1CMR Phantom (1.5T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000064T1CMR Phantom (3.0T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000071T2CMR PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000088R2*/T2* PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
00812266030673LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00812266030680LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
EIBASR020010myQA® SRS Phantom CyberknifeIBA Dosimetry GmbHIXG2023-10-10
00850019946505Standard Imaging Lucy 3D QA PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946512Standard Imaging MIMI PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946529Standard Imaging Stereotactic Dose Verification PhantomSTANDARD IMAGING INC.IXG2023-06-22