FDA.reportPublic FDA data

DTS-3000

Primary DI
08809802646971
Brand
DTS-3000
Company
DAESUNG MAREF CO.,LTD.
Model
DTSW310
Device description
Main Device 1ea
Published
2025-12-19
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
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809802646971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809802646971088098026469718809802646971

GMDN Terms#

Term, Definition table
TermDefinition
Surgical pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688817949
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
08809802648494DVT-SERIESDS0312026-02-09
08809802648500DVT-SERIESDS0332026-02-09
18809802648491DVT-SERIESDS0312026-02-09
18809802648507DVT-SERIESDS0332026-02-09
08809802645301SP-1000SP10100-LL2025-12-19
08809802645318SP-1000SP10100-LX2025-12-19
08809802645325SP-1000SP10100-LZ2025-12-19
08809802645462SP-2000SP20100-LL2025-12-19
08809802645479SP-2000SP20100-LX2025-12-19
08809802645486SP-2000SP20100-LZ2025-12-19
08809802646131LX9maxLX9M100-LL2025-12-19
08809802646148LX9maxLX9M100-LX2025-12-19
08809802646155LX9maxLX9M100-LZ2025-12-19
08809802646810DVT-2600DVT3120-DT2025-12-19
08809802646858DVT-4000SDVT4100-DT2025-12-19
08809802645295SP-1000SP101002025-12-19
18809802645308SP-1000SP10100-LL2025-12-19
18809802645315SP-1000SP10100-LX2025-12-19
18809802645322SP-1000SP10100-LZ2025-12-19
08809802645332SP-1000SP10100-RL2025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106251MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106268MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106275MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106282MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106299MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106305MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15