FDA.reportPublic FDA data

MDR-600HD

Primary DI
04573499760015
Brand
MDR-600HD
Company
Dongguan Teac Electronics Co., Ltd.
Model
1921062050
Device description
MDR-600HD VIDEO REC
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573499760015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573499760015045734997600154573499760015

GMDN Terms#

Term, Definition table
TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images; it may incorporate a small screen intended to reference what images are being captured, but not intended to be used as a monitor. It is typically a portable device with a direct electronic signal connection to the diagnostic/surgical device; it may also have playback and/or storage file capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544883143
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04907034602155UR-4MD19210620222025-07-31
04907034602162UR-4MD19210620402025-07-31
04907034602230UR-4MD19210620452025-07-31
04907034602261UR-4MD19210621012025-07-31
04907034602278UR-4MD19210621202025-07-31
04907034602285UR-4MD19210621402025-07-31
04907034602315UR-4MD19210621222025-07-31
04907034602322UR-4MD19210621252025-07-31
04907034602339UR-4MD19210621452025-07-31
04907034602377UR-4MD19210621602025-07-31
04907034602384UR-4MD19210621652025-07-31
04907034602391UR-4MD19210620752025-07-31
04907034602445UR-4MD19210621612025-07-31
04573499760077MDR-600HD19210621512025-04-04
04907034602001UR-4MD1921062001M00679139002020-09-24
04907034602018UR-4MD19210620912020-09-24
04907034602032UR-4MD19210620922020-09-24
04907034602049UR-4MD19210620002020-09-24
04907034602094UR-4MD19210620202020-09-24
04907034602148UR-4MD19210620252020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850631008797Roentgen WorksBrit Systems, LLCLMB2025-11-20
00850631008766Roentgen WorksBrit Systems, LLCLMB2025-10-01
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00850631008759Roentgen WorksBrit Systems, LLCLMB2025-08-14
00850631008742Roentgen WorksBrit Systems, LLCLMB2025-08-07
00850631008735Roentgen WorksBrit Systems, LLCLMB2025-07-31
04907034602155UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602162UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602230UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602247UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602254UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602261UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602278UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602285UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602308UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602315UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602322UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602339UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602346UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602353UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31