FDA.reportPublic FDA data

Meicen

Primary DI
06977071931431
Brand
Meicen
Company
Guangdong Meicen Medical Equipment Co., Ltd.
Model
M3038-SUA482B
Device description
3.0mm, 10"x12", Extended U-Frame EMRT-8315
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977071931431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071931431069770719314316977071931431

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).

Regulatory Flags#

DUNS number
724689169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977071931271MeicenM30RB-VSA670W2026-06-26
06977071931288MeicenM30RB-VSA672W2026-06-26
06977071931295MeicenM30RB-VSB673W2026-06-26
06977071931301MeicenM3038-SSB480B2026-06-26
06977071931318MeicenM2422-SVA190W2026-06-26
06977071931325MeicenM30RA-SSA610B2026-06-26
06977071931332MeicenM30RB-SSA672B2026-06-26
06977071931349MeicenM30RB-SSB672B2026-06-26
06977071931356MeicenM2422-SVB190W2026-06-26
06977071931363MeicenM30RB-VSB670W2026-06-26
06977071931400MeicenM2422-SUA190BM2422-SUA190B2026-06-26
06977071931417MeicenM3038-SUA480B2026-06-26
06977071931424MeicenM2422-SUA193B2026-06-26
06977071931448MeicenM24RB-SUA640B2026-06-26
06977071931455MeicenM24RA-SUA581B2026-06-26
06977071931462MeicenM24RB-SSA640B2026-06-26
06977071931479MeicenM24RA-SVA580W2026-06-26
06977071931486MeicenM3038-SVA480W2026-06-26
06977071931493MeicenM24RA-SVB580W2026-06-26
06977071931509MeicenM3038-SVB480W2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977071931271MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931288MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931295MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931301MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931318MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931325MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931332MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931349MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931356MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931363MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931400MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931417MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931424MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931448MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931455MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931462MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931479MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931486MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931493MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931509MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931516MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931523MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931585MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931592MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931608MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931615MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931622MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931639MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931646MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931653MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26