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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FIT SA F10 A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25610 ()
Y2561

  • Dental composite resin
FIT SA F10 A1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25600 ()
Y2560

  • Dental composite resin
FIT SA F03B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25540 ()
Y2554

  • Dental composite resin
FIT SA F03A4 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25530 ()
Y2553

  • Dental composite resin
FIT SA F03A3 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25520 ()
Y2552

  • Dental composite resin
FIT SA F03A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25510 ()
Y2551

  • Dental composite resin
FIT SA F03A1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25500 ()
Y2550

  • Dental composite resin
BEAUTIFIL KIDS SA A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10110 ()
Y1011

  • Dental composite resin
RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software
25SH 14X36IN E BLUE X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976046050 ()
  • 00889976046058 ()
6046056

  • Medical x-ray film, screen
25SH 14X36IN E GREEN X-RAY WB (FLAT)
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045978 ()
  • 00889976045976 ()
6045975

  • Medical x-ray film, screen
25SH 14X36IN (FLAT) BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976041383 ()
  • 00889976041381 ()
6041388

  • Medical x-ray film, screen
25SH 14X36IN (FLAT) GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
Not in Commercial Distribution

  • 60889976041376 ()
  • 00889976041374 ()
6041370

  • Medical x-ray film, screen
10SC 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971933980 ()
  • 00088997193398 ()
1933985

  • Digital imaging cassette/phosphor plate
10SC 18X24CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971157539 ()
  • 00088997115753 ()
1157536

  • Digital imaging cassette/phosphor plate
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of normal level.
STRECK, INC.
218752
In Commercial Distribution

  • 50844509000612 ()

  • Total Volume: 2.5 Milliliter
218752

  • Full blood count IVD, control
KIT, OPTIGEN US Environmental 36 (40ND)
Minaris Medical America, Inc.
85168
In Commercial Distribution

  • 00813382012178 ()
85168

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (40ND)
Minaris Medical America, Inc.
85167
In Commercial Distribution

  • 00813382012154 ()
85167

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
UP20 Negative Control Reagent
Minaris Medical America, Inc.
80108
Not in Commercial Distribution

  • 00813382010358 ()
  • 00813382010365 ()
80108

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
Kit, Southern
Minaris Medical America, Inc.
84508
Not in Commercial Distribution

  • 00813382010334 ()
84508

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
UP20 Positive Control Reagent
Minaris Medical America, Inc.
80107
Not in Commercial Distribution

  • 00813382010280 ()
  • 00813382010341 ()
80107

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
CLA Pos Ctrl Serum
Minaris Medical America, Inc.
93026
In Commercial Distribution

  • 00813382010198 ()
  • 00813382010303 ()
93026

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
CLA Neg Ctrl Serum
Minaris Medical America, Inc.
94173
In Commercial Distribution

  • 00813382010181 ()
  • 00813382010297 ()
94173

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
KIT, Moderate Food
Minaris Medical America, Inc.
84518
In Commercial Distribution

  • 00813382010174 ()
84518

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Western Inhalant
Minaris Medical America, Inc.
84511
Not in Commercial Distribution

  • 00813382010167 ()
84511

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Southwestern Inhalant
Minaris Medical America, Inc.
84509
Not in Commercial Distribution

  • 00813382010150 ()
84509

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Southeastern Inhalant
Minaris Medical America, Inc.
84507
In Commercial Distribution

  • 00813382010143 ()
84507

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Pediatric Comprehensive
Minaris Medical America, Inc.
84506
Not in Commercial Distribution

  • 00813382010136 ()
84506

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Northwestern Inhalant
Minaris Medical America, Inc.
84505
Not in Commercial Distribution

  • 00813382010129 ()
84505

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Northeastern Inhalant
Minaris Medical America, Inc.
84504
In Commercial Distribution

  • 00813382010112 ()
84504

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Eastern
Minaris Medical America, Inc.
84502
In Commercial Distribution

  • 00813382010105 ()
84502

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
OPTIGEN Negative Control
Minaris Medical America, Inc.
82062
In Commercial Distribution

  • 00813382010099 ()
  • 00813382010310 ()
82062

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
OPTIGEN Positive Control
Minaris Medical America, Inc.
82061
In Commercial Distribution

  • 00813382010082 ()
  • 00813382010327 ()
82061

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Environmental 36 (20T)
Minaris Medical America, Inc.
85068
In Commercial Distribution

  • 00813382010037 ()
85068

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (100ND)
Minaris Medical America, Inc.
85267
In Commercial Distribution

  • 00813382010020 ()
85267

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022519 ()
A11256

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021741 ()
5351025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021734 ()
5331025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021710 ()
5320025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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