FDA.reportPublic FDA data

Olympus

Primary DI
15019778006505
Brand
Olympus
Company
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
Model
TC-C4
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019778006508Direct MarkingGS10
15019778006505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019778006508050197780065085019778006508
1501977800650515019778006505

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction pumpAn electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Regulatory Flags#

DUNS number
217061423
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
15019778008653OlympusARV110K100376162023-10-30
15019778008660OlympusARV120K100376172023-10-30
15019778008677OlympusARV130K100376182023-10-30
15019778008684OlympusARV140K100376192023-10-30
05019778008656OlympusARV110K100376162023-10-30
05019778008663OlympusARV120K100376172023-10-30
05019778008670OlympusARV130K100376182023-10-30
05019778008687OlympusARV140K100376192023-10-30
15019778000879OlympusEndosonic2016-09-19
15019778007700OlympusMAJ-2207K100350022023-07-18
15019778007717OlympusMAJ-2208K100350032023-07-18
15019778007724OlympusMAJ-2209K100350042023-07-18
15019778007731OlympusMAJ-2210K100350052023-07-18
15019778008516OlympusMAJ-2220K100371612023-07-18
15019778008523OlympusMAJ-2221K100371622023-07-18
15019778008530OlympusMAJ-2222K100371632023-07-18
15019778008547OlympusMAJ-2223K100371642023-07-18
15019778008646OlympusWide-Eye Polyp TrapK100376262023-07-18
15019778005072OlympusMAJ-1681K100266412023-07-05
15019778005089OlympusMAJ-1682K100266862023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810004820460Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
00810004820463Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820149Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820705Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
10810004820712Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
10810004820729Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
10810004820736Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
10810004820750Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
00810004820128Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820135Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820142Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820708Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
00810004820715Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
00810004820722Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
00810004820739Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
00810004820753Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
04055207001189NARichard Wolf GmbHFEM2024-08-06
04055207025024RIWOMOBILRichard Wolf GmbHFEM2024-08-06
04051423002085TV-adapterasap endoscopic products GmbHFEM2024-07-11
04055207008928NARichard Wolf GmbHFEM2024-05-21
04055207009086NARichard Wolf GmbHFEM2024-05-21
04055207009116NARichard Wolf GmbHFEM2024-05-21
08800182600041ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600195ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600331ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600355ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
06972197480887PylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480894TrolleyHunan Vathin Medical Instrument Co., LtdFEM2023-10-31