FDA.reportPublic FDA data

lmaging Processor System (lncluding Light Source)

Primary DI
06973786290078
Brand
lmaging Processor System (lncluding Light Source)
Company
Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)
Model
PL-1000
Published
2023-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
KQMCamera, Surgical And Accessories
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973786290204PackageGS11In Commercial Distribution
06973786290078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697378629020416973786290204
06973786290078069737862900786973786290078

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing/light source systemA mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.

Regulatory Flags#

DUNS number
778435473
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
06973786291563Flexible Video-CholedochoscopeCHV-110J-U2025-03-20
06973786291570Flexible Video-CholedochoscopeCHV-US120J-U2025-03-19
06973786290337Disposable Endoscope Valves KitSG-DVK-OL-2002024-10-25
06973786290344Disposable Endoscope Valves KitSG-DVK-OL-200E2024-10-25
06973786290368Disposable Endoscope Valves KitSG-DVK-FJ-7002024-10-25
06973786290375Disposable Endoscope Valves KitSG-DVK-FJ-700E2024-10-25
06973786290399Disposable Endoscope Valves KitSG-DVK-PT-I10902024-10-25
06973786290405Disposable Endoscope Valves KitSG-DVK-PT-I1090E2024-10-25
06973786290139lmaging Processor System (lncluding Light Source)PL-21002023-07-26
06973786291396Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(STD)2024-09-14
06973786291402Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(STD)2024-09-14
06973786290559Flexible Video-Choledo-Cysto-UreteroscopeCHV-100-E2023-07-26
06973786290566Flexible Video-Choledo-Cysto-UreteroscopeCHV-100T-E2023-07-26
06973786290573Flexible Video-Choledo-Cysto-UreteroscopeCHV-US100-H2023-07-26
06973786290580Flexible Video-Choledo-Cysto-UreteroscopeUV-100-E2023-07-26
06973786290597Flexible Video-Choledo-Cysto-UreteroscopeUV-110-E2023-07-26
06973786290603Flexible Video-Choledo-Cysto-UreteroscopeUV-100T-E2023-07-26
06973786290610Flexible Video-Choledo-Cysto-UreteroscopeUV-110T-E2023-07-26
06973786290627Flexible Video-Choledo-Cysto-UreteroscopeUV-US100-H(REV)2023-07-26
06973786290634Flexible Video-Choledo-Cysto-UreteroscopeUV-US110-H(REV)2023-07-26

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