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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-056
In Commercial Distribution

  • M896AMS500350560 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-053
In Commercial Distribution

  • M896AMS500350530 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-050
In Commercial Distribution

  • M896AMS500350500 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-056
In Commercial Distribution

  • M896AMS500220560 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-053
In Commercial Distribution

  • M896AMS500220530 ()


  • Haematological concentrate system preparation kit, platelet concentration
Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-050
In Commercial Distribution

  • M896AMS500220500 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Biosafe S.A.
CryoSC-Db Seal positioner
In Commercial Distribution

  • 07640125650570 ()
7035

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
CryoSC-D Seal positioner
Not in Commercial Distribution

  • 07640125650563 ()
7026

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Insertion Tool
Not in Commercial Distribution

  • 07640125650556 ()
  • 07640125650648 ()
7030

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Metal Storage Canister
In Commercial Distribution

  • 07640125650549 ()
  • 07640125650532 ()
  • 07640125650631 ()
7012

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Overwrap Bag
In Commercial Distribution

  • 07640125650518 ()
  • 07640125650525 ()
4085

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for Bioarchive
Not in Commercial Distribution

  • 07640125650501 ()
7031

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for cryopreservation
Not in Commercial Distribution

  • 07640125650495 ()
7011

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
FB-100.2b
Not in Commercial Distribution

  • 07640125650419 ()
  • 07640125650402 ()
10041

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.2
Not in Commercial Distribution

  • 7640125650396 ()
  • 07640125650389 ()
10032

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.1
Not in Commercial Distribution

  • 07640125650372 ()
  • 07640125650365 ()
10023

  • Blood/tissue storage/culture container
DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
4 x 6 ml
In Commercial Distribution

  • 07640137340605 ()
213285

  • Multiple immunohaematology test IVD, control
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Bio-Rad Medical Diagnostics GmbH
12008722
In Commercial Distribution

  • 03610522055685 ()
12008722

  • Column agglutination IVD
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution

  • B73810071 ()


  • Haematological concentrate system
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution

  • 00817955020010 ()


  • Blood bank information system application software
The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder
The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000223 ()
  • 00866305000226 ()
480-B40-00-1274

  • Laboratory tubing welder
Blood mixing and weighing device
Transmed Medizintechnik GmbH & Co. KG
TRANSWAAG PRO
In Commercial Distribution

  • 04028339620139 ()
97.8700.105

  • Blood weighing scale
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