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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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DBD-MTO ANGIO KIT COM HOSP ANDERSON PG
MEDLINE INDUSTRIES, INC.
65031863
In Commercial Distribution

  • 10193489060232 ()
65031863

  • Angiography kit
MTO LEFT HEART KIT CENTRAL MICHIGAN COM
MEDLINE INDUSTRIES, INC.
60033151
In Commercial Distribution

  • 20193489042464 ()
  • 10193489042467 ()
60033151

  • Angiography kit
MTO SINGLE MONING KIT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
60030544
In Commercial Distribution

  • 20193489041924 ()
  • 10193489041927 ()
60030544

  • Angiography kit
MTO 4 VALVE W/PROTECTION STATION COM
MEDLINE INDUSTRIES, INC.
60031052
In Commercial Distribution

  • 30193489087264 ()
  • 10193489087260 ()
60031052

  • Angiography kit
SBFLCP-CO COM RA (M) FL CUP 25P
Peter Brasseler Holdings, LLC
5028343S0
In Commercial Distribution

  • 00887919878339 ()


  • Dental abrasive point, reusable
RECL DLX CL CR PVT ARM COM
GF HEALTH PRODUCTS, INC.
IN601P-COM
In Commercial Distribution

  • M368IN601PCOM1 ()


  • Reclining chair
Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative kinetic determination of Lactate Dehydrogenase activity in serum.
IDG/SANZAY Corporation
1
In Commercial Distribution

  • 00850053916137 ()

  • Total Volume: 150 Milliliter
  • Total Volume: 300 Milliliter
  • Total Volume: 1 Liter
C343

  • Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137012005 ()
  • 00812137012333 ()
501-413

  • Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent
MCM5 Control Slides
BIO SB, INC.
BSB-9270-CS
In Commercial Distribution

  • B502BSB9270CS0 ()
BSB-9270-CS

  • Minichromosome maintenance protein 5 (MCM5) IVD, control
MCM5, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB68970 ()
BSB 6897

  • Minichromosome maintenance protein 5 (MCM5) IVD, control
DEL SYS DCS-C4-18F-US COM 26/29/31 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-US
Not in Commercial Distribution

  • 00643169565623 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
COM PLACM INST DE #4 TIN STD H
NORDENT MANUFACTURING INC
PFI4T
In Commercial Distribution

  • 00840018635975 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #3 TIN STD H
NORDENT MANUFACTURING INC
PFI3T
In Commercial Distribution

  • 00840018635937 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #2 TIN STD H
NORDENT MANUFACTURING INC
PFI2T
In Commercial Distribution

  • 00840018635883 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #1 TIN STD H
NORDENT MANUFACTURING INC
PFI1T
In Commercial Distribution

  • 00840018635814 ()


  • Margin finishing dental file/rasp, reusable
COM PLACE INST DE LR 2 TIN DL-
NORDENT MANUFACTURING INC
REPFILR2T
In Commercial Distribution

  • 00840018637689 ()


  • Margin finishing dental file/rasp, reusable
COM PLACEM INST DE, #40-30 TIN, DL HNDL
NORDENT MANUFACTURING INC
REPFI40T-30T
In Commercial Distribution

  • 00840018647244 ()


  • Margin finishing dental file/rasp, reusable
909 P37,Z4,2L,1LD,AUDIO & COM SWAP,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-990-353
In Commercial Distribution

  • 00840828100359 ()
178

  • Electrical mains power extension cable
Hose 1ea, Com cable 1ea (1 set box)
DAESUNG MAREF CO.,LTD.
1000860
In Commercial Distribution

  • 18809315679814 ()
  • 08809315679817 ()
  • 28809315679811 ()


  • Hand/wrist continuous passive motion exerciser
MTO 3 WAY MANIFOLD KIT PARMA COM GEN
MEDLINE INDUSTRIES, INC.
601621410
In Commercial Distribution

  • 20193489071884 ()
  • 10193489071887 ()
601621410

  • Angiography kit
MTO LEFT HEART KIT SAN ANGELO COM MED
MEDLINE INDUSTRIES, INC.
60010991
In Commercial Distribution

  • 20193489040439 ()
  • 10193489040432 ()
60010991

  • Angiography kit
50PSI PRST COM AIR GAS REG CGA346 MRI
OHIO MEDICAL, LLC
GR-346-DCXX-XXM
In Commercial Distribution

  • 00628101618247 ()
GR-346-DCXX-XXM

  • Non-fixed medical gas cylinder regulator
MTO LEFT HEART KIT PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 10193489076363 ()
651621415

  • Angiography kit
MTO LEFT HEART W/DT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
650305414
In Commercial Distribution

  • 10193489075151 ()
650305414

  • Angiography kit
MTO LEFT HEART KIT SEVEN RIVERS COM HOSP
MEDLINE INDUSTRIES, INC.
65193662
In Commercial Distribution

  • 10193489063233 ()
65193662

  • Angiography kit
STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN
Crest Healthcare Supply
116648
In Commercial Distribution

  • B4841166480 ()


  • Nurse call system
ABVISER AV IAP COM W/ARGON T'DUCER, POLE
CONVATEC, PURCHASING DEPARTMENT
420760
Not in Commercial Distribution

  • 00768455127993 ()
  • 00768455128136 ()
420760

  • Intra-abdominal pressure measurement set, electronic
MMA (Methylmalonic Acid) Level 1
UTAK LABORATORIES, INC.
74053
In Commercial Distribution

  • B800740535 ()
  • B800740530 ()

  • Total Volume: 5 Milliliter
74053

  • Methylmalonic acid (MMA) IVD, control
HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.
4010-03-09-T1
In Commercial Distribution

  • 10841911101502 ()
  • 00841911101505 ()

  • Needle Gauge: 9 Gauge


  • Radiological image marker, implantable
Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018799 ()
LKT25

  • Cell centrifugation/density gradient separation reagent IVD
Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018775 ()
LK-50-T

  • Cell centrifugation/density gradient separation reagent IVD
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018713 ()
LATP240

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018706 ()
LATP1HD

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018690 ()
LATP140X2

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018683 ()
LATP140

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018676 ()
LATP1288

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018669 ()
LATP1240

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018652 ()
LATM20X5P

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018645 ()
LATM120P

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018638 ()
LATM10X5P

  • HLA class I & II antibody screening IVD, kit, multiplex
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