FDA.reportPublic FDA data

TCV-FAC-21W(SBF)(46060)

Primary DI
04582539071295
Brand
TCV-FAC-21W(SBF)(46060)
Company
TOKYO GIKEN INC.
Model
W134
Device description
This device is intended to remove droplets scattered from the oral cavity. This equipment is an electrical powered suction pumps as suction source.
Published
2020-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBRUnit, Suction Operatory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582539071295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582539071295045825390712954582539071295

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction systemAn assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692497670
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582539071233Free arm arteo-F(120V)W1282020-10-01
04582539071240Free arm arteo-I(120V)W1292020-10-01
04582539071257Free arm arteo-T(120V)W1302020-10-01
04582539071264TCV-FAC-21S(SBF)(23060)W1312020-10-01
04582539071271TCV-FAC-21W(SBF)(23060)W1322020-10-01
04582539071288TCV-FAC-21S(SBF)(46060)W1332020-10-01
04582539071042Free arm arteo-S(120V)W0982020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709122286MidmarkMIDMARK CORPORATIONEBR2026-02-20
06971119541910Suction machineGuangdong JINME Medical Technology Co., Ltd.EBR2025-07-15
07898938244220MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244237MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
07898938244732MaquiraMaquira Industria de Produtos Odontologicos S/AEBR2024-08-07
00810032660710Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660758Isolite, i2ZYRIS, INC.EBR2024-04-19
00810032660765Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660772Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660789Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660796Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660802Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660819Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660826Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660833Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660840Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660857Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660864Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660871Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660888Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660901Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660925Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660932Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660949Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660956Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660963Isolite, i3ZYRIS, INC.EBR2024-04-19
00810032660970IsovacZYRIS, INC.EBR2024-04-19
00810032660987Anterior MouthpieceZYRIS, INC.EBR2024-04-19
00810032661007Anterior Hose KitZYRIS, INC.EBR2024-04-19
00810032661014Operating Room AdapterZYRIS, INC.EBR2024-04-19