FDA.reportPublic FDA data

Meicen

Primary DI
06977071936009
Brand
Meicen
Company
Guangdong Meicen Medical Equipment Co., Ltd.
Model
/
Published
2024-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06977071936009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071936009069770719360096977071936009

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

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
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
06977071931431MeicenM3038-SUA482B2026-06-26
06977071931448MeicenM24RB-SUA640B2026-06-26
06977071931455MeicenM24RA-SUA581B2026-06-26
06977071931462MeicenM24RB-SSA640B2026-06-26
06977071931479MeicenM24RA-SVA580W2026-06-26
06977071931486MeicenM3038-SVA480W2026-06-26
06977071931493MeicenM24RA-SVB580W2026-06-26

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
06977071931431MeicenGuangdong 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