DTS-3000

GUDID 18809315676592

AC SINGLE CUFF (DTC-SA07) 1ea

DAESUNG MAREF CO.,LTD.

Surgical pneumatic tourniquet system
Primary Device ID18809315676592
NIH Device Record Key48036fbd-8da3-445a-a672-dfb127af0831
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTS-3000
Version Model NumberDTC-SA07
Company DUNS688817949
Company NameDAESUNG MAREF CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809315676595 [Primary]
GS118809315676592 [Package]
Contains: 08809315676595
Package: Box [4 Units]
In Commercial Distribution
GS128809315676599 [Package]
Contains: 08809315676595
Package: Box [7 Units]
In Commercial Distribution
GS138809315676596 [Package]
Contains: 08809315676595
Package: Box [17 Units]
In Commercial Distribution
GS148809315676593 [Package]
Contains: 08809315676595
Package: Box [12 Units]
In Commercial Distribution
GS158809315676590 [Package]
Contains: 08809315676595
Package: Box [21 Units]
In Commercial Distribution
GS168809315676597 [Package]
Contains: 08809315676595
Package: Box [36 Units]
In Commercial Distribution

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-24
Device Publish Date2021-06-16

On-Brand Devices [DTS-3000]

18809315676608AC SINGLE CUFF (DTC-SA15) 1ea
18809315676592AC SINGLE CUFF (DTC-SA07) 1ea
18809315676585AC SINGLE CUFF (DTC-SA06) 1ea
18809315676578AC SINGLE CUFF (DTC-SA05) 1ea
18809315676561AC SINGLE CUFF (DTC-SA02) 1ea
18809315676554AC SINGLE CUFF (DTC-SA01) 1ea
18809315676530IOP Sensor 1ea
18809315676523GRAY MAIN HOSE 1ea
18809315676516BLUE MAIN HOSE 1ea
18809315676509RED MAIN HOSE 1ea
18809315676493Cone Double Cuff (DTC-CD27) 1ea
18809315676486Cone Double Cuff (DTC-CD26) 1ea
18809315676479Cone Double Cuff (DTC-CD25) 1ea
18809315676431Double Cuff(DTC-D07) 1ea
18809315676370Double Cuff (DTC-D06) 1ea
18809315676356Double Cuff (DTC-D05) 1ea
18809315676332Double Cuff (DTC-D04) 1ea
18809315676264Cone Single Cuff (DTC-C27) 1ea
18809315676257Cone Single Cuff (DTC-C26) 1ea
18809315676240Cone Single Cuff (DTC-C25 1ea)
18809315676233Gray hose 1ea
18809315676226Blue hose 1ea
18809315676219Red hose 1ea
08809315676199Hose set (Red 1ea, Blue 1ea, Gray 2ea)
08809315676182Device 1ea, AC SINGLE CUFF(DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea)
08809315676175Device 1ea, Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cuff (
18809315676165AC SINGLE CUFF (DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea)
18809315676158Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff (DTC-C26 1ea) Double Cuff (DTC-D04 1ea,
18809315676141Single Cuff(DTC-S08) 1ea
18809315676134Single Cuff(DTC-S07) 1ea
18809315676127Single Cuff(DTC-S06) 1ea
18809315676110Single Cuff (DTC-S05) 1ea
18809315676103Single Cuff (DTC-S04) 1ea
18809315676097Single Cuff (DTC-S02) 1ea
08809315676076Device 1ea
08809802643956Device 1ea, AC Single Cuff(DTC-SA02 1ea, DTC-SA06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cu
08809802643284Device 1ea, Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor [One set box]
08809315676304Device 1ea, Single Cuff(DTC-S02 1ea, DTC-S04 1ea), Cone Single Cuff(DTC-C25 1ea, DTC-C26 1ea, DT
08809802644236Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea

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