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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No Description
BIOCARE MEDICAL LLC
API3001DSAA
In Commercial Distribution

  • 00847627003850 ()


  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM370TSAA
In Commercial Distribution

  • 00847627011718 ()


  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM315-10M
In Commercial Distribution

  • 00810119677921 ()

  • Total Volume: 10 Milliliter
AM315-10M

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX315-YCD
In Commercial Distribution

  • 00810119676528 ()
AX315-YCD

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM946-10M
In Commercial Distribution

  • 00810119679567 ()

  • Total Volume: 10 Milliliter
AM946-10M

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AN849-5M
In Commercial Distribution

  • 00810119672698 ()

  • Total Volume: 6 Milliliter
AN849-5M

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM315-5M
In Commercial Distribution

  • 00810119670151 ()

  • Total Volume: 6 Milliliter
AM315-5M

  • Multiple bladder tissue/tumour marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU315-UC
In Commercial Distribution

  • 00810119675125 ()

  • Total Volume: 1 Milliliter
MU315-UC

  • Multiple bladder tissue/tumour marker IVD, antibody
Syringe, 20 cc
DEROYAL INDUSTRIES, INC.
77-400108
In Commercial Distribution

  • 50749756324071 ()
  • 00749756324076 ()


  • General-purpose syringe, single-use
Syringe, 20 cc
DEROYAL INDUSTRIES, INC.
77-400107
In Commercial Distribution

  • 50749756324057 ()
  • 00749756324052 ()


  • General-purpose syringe, single-use
Syringe, 20 cc
DEROYAL INDUSTRIES, INC.
77-400106
In Commercial Distribution

  • 50749756324033 ()
  • 00749756324038 ()


  • General-purpose syringe, single-use
Syringe, 20 cc
DEROYAL INDUSTRIES, INC.
77-400105
In Commercial Distribution

  • 50749756323999 ()
  • 00749756323994 ()


  • General-purpose syringe, single-use
Washer-Pasteuerizer/High Level Disinfector
CENORIN, L.L.C.
610HT
In Commercial Distribution

  • 00852494007085 ()


  • Pasteurization water bath
Washer-Pasteurizer/High Level Disinfector
CENORIN, L.L.C.
610
In Commercial Distribution

  • 00852494007078 ()


  • Pasteurization water bath
Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe
Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

  • 05055844901575 ()
USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe
Del(20q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution



  • Myelodysplastic syndrome (MDS) IVD, probe
Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
BOEKEL INDUSTRIES, INC.
FS100
In Commercial Distribution

  • 00863626000294 ()
FS100

  • Platelet incubator
No Description
BOEKEL INDUSTRIES, INC.
301650
In Commercial Distribution

  • 00863626000249 ()


  • Platelet incubator
No Description
BOEKEL INDUSTRIES, INC.
301550
In Commercial Distribution

  • 00863626000232 ()


  • Platelet incubator
Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC2200-Pro
In Commercial Distribution

  • 00816394021688 ()


  • Platelet incubator
Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC3200-PRO
In Commercial Distribution

  • 00816394021671 ()


  • Platelet incubator
Environmentatal chamber for storage of platelet concentrate
HELMER, INC.
PC4200-Pro
In Commercial Distribution

  • 00816394021664 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC1200-Pro
In Commercial Distribution

  • 00816394020964 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC900-Pro
In Commercial Distribution

  • 00816394020957 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC100-Pro
In Commercial Distribution

  • 00816394020940 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC4200i
In Commercial Distribution

  • 00816394020780 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC3200i
In Commercial Distribution

  • 00816394020773 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC2200i
In Commercial Distribution

  • 00816394020766 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC1200i
Not in Commercial Distribution

  • 00816394020759 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC900i
Not in Commercial Distribution

  • 00816394020742 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC100i
Not in Commercial Distribution

  • 00816394020735 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC4200h
In Commercial Distribution

  • 00816394020728 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC3200h
In Commercial Distribution

  • 00816394020711 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC2200h
In Commercial Distribution

  • 00816394020704 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC1200h
Not in Commercial Distribution

  • 00816394020698 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC900h
Not in Commercial Distribution

  • 00816394020681 ()


  • Platelet incubator
Platelet Incubator
HELMER, INC.
PC100h
Not in Commercial Distribution

  • 00816394020674 ()


  • Platelet incubator
20 cc Silicone Balloon
H & A Mui Enterprises Inc
ZC1BAL/BM/20.4
In Commercial Distribution

  • 00678467503831 ()


  • Gastrointestinal motility manometric catheter, non-electronic
No Description
BIOCARE MEDICAL LLC
TWN20M
In Commercial Distribution

  • 00847627014689 ()


  • Immunohistochemistry wash buffer reagent IVD
No Description
BIOCARE MEDICAL LLC
TWN20L
In Commercial Distribution

  • 00847627014672 ()


  • Immunohistochemistry wash buffer reagent IVD
No Description
BIOCARE MEDICAL LLC
TWN20H
In Commercial Distribution

  • 00847627014665 ()


  • Immunohistochemistry wash buffer reagent IVD
20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)
PARKELL, INC.
S475
In Commercial Distribution

  • 10810000527585 ()
  • 00810000527588 ()
S475

  • Dental mirror, reusable
Chart Visual Acuity
Illuminix Industries LLC
SMART CHART
In Commercial Distribution

  • 00860010833285 ()


  • Visual acuity projector
Visual Screening, DIGITAL VISUAL ACUITY TEST
Micro Medical Devices, Inc.
VS2000
In Commercial Distribution

  • 00853569007146 ()
900-0011-02

  • Visual acuity projector
No Description
Lianyungang Tiannuo Optical Instrument Co., Ltd.
TN-990L
In Commercial Distribution

  • 06945033902065 ()


  • Visual acuity projector
No Description
Lianyungang Tiannuo Optical Instrument Co., Ltd.
TN-500L
In Commercial Distribution

  • 06945033902058 ()


  • Visual acuity projector
Blood storage refrigerator
B Medical Systems SARL
MT100
In Commercial Distribution

  • 05450104061837 ()
991.2370.**

  • Blood refrigerator/incubator
Visual Acuity Chart
TOPCON HEALTHCARE INC
VisiChart II
In Commercial Distribution

  • 00850053428500 ()


  • Visual acuity projector
No Description
The Hilsinger Company Parent LLC
OCVR-01
In Commercial Distribution

  • 00850040295818 ()


  • Visual acuity projector
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