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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CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-02
In Commercial Distribution

  • 00380740119836 ()
09H7202

  • Full blood count IVD, control
CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-01
In Commercial Distribution

  • 00380740119829 ()
09H7201

  • Full blood count IVD, control
CELL-DYN 18 PLUS CALIBRATOR
ABBOTT LABORATORIES
09H70-01
In Commercial Distribution

  • 00380740020347 ()
09H7001

  • Full blood count IVD, calibrator
CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-02
In Commercial Distribution

  • 00380740020330 ()
09H6902

  • Full blood count IVD, control
CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-01
In Commercial Distribution

  • 00380740020323 ()
09H6901

  • Full blood count IVD, control
CELL-DYN RETIC PLUS CONTROL
ABBOTT LABORATORIES
08H62-01
In Commercial Distribution

  • 00380740017149 ()
08H6201

  • Reticulocyte count IVD, control
CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-02
In Commercial Distribution

  • 00380740017118 ()
08H5902

  • Full blood count IVD, control
CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-01
In Commercial Distribution

  • 00380740017101 ()
08H5901

  • Full blood count IVD, control
CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control
CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control
CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator
SUPER SNAP POLYSTRIPS, GN/RED
SHOFU DENTAL CORPORATION
L526
In Commercial Distribution

  • 04548162235398 ()
L526

  • Dental abrasive strip, single-use
SUPER SNAP POLYSTRIPS, BK/VT 1
SHOFU DENTAL CORPORATION
L525
In Commercial Distribution

  • 04548162235381 ()
L525

  • Dental abrasive strip, single-use
Super-Snap Rainbow Technique Kit
SHOFU DENTAL CORPORATION
0500
In Commercial Distribution

  • 04548162235367 ()
0500

  • Dental abrasive disk, single-use
Paste Dentin
TOKUYAMA DENTAL CORPORATION
16313
In Commercial Distribution

  • 04548190163137 ()


  • Dental composite resin
Paste Clear
TOKUYAMA DENTAL CORPORATION
16311
In Commercial Distribution

  • 04548190163113 ()


  • Dental composite resin
Kit Dentin
TOKUYAMA DENTAL CORPORATION
16308
In Commercial Distribution

  • 04548190163083 ()


  • Dental composite resin
PASTE BROWN
TOKUYAMA DENTAL CORPORATION
16178
In Commercial Distribution

  • 04548190161782 ()


  • Dental composite resin
PASTE UNIVERSAL
TOKUYAMA DENTAL CORPORATION
16158
In Commercial Distribution

  • 04548190161584 ()


  • Dental composite resin
KIT UNIVERSAL
TOKUYAMA DENTAL CORPORATION
16148
In Commercial Distribution

  • 04548190161485 ()


  • Dentine bonding agent/set
  • Dental composite resin
Bond B
TOKUYAMA DENTAL CORPORATION
15218
In Commercial Distribution

  • 04548190152186 ()


  • Dentine bonding agent/set
Standard-kit
TOKUYAMA DENTAL CORPORATION
14951
In Commercial Distribution

  • 04548190149513 ()
  • 94548190149516 ()


  • Dentine adhesive
Pen, Intro-kit
TOKUYAMA DENTAL CORPORATION
14937
In Commercial Distribution

  • 04548190149377 ()


  • Dentine adhesive
Kit
TOKUYAMA DENTAL CORPORATION
14912
In Commercial Distribution

  • 04548190149124 ()


  • Dentine adhesive
Bonding Agent A
TOKUYAMA DENTAL CORPORATION
14736
In Commercial Distribution

  • 04548190147366 ()


  • Dentine adhesive
No Description
TOKUYAMA DENTAL CORPORATION
20133
In Commercial Distribution

  • 04548190201334 ()


  • Denture reliner, hard
Primer 2
TOKUYAMA DENTAL CORPORATION
16338
In Commercial Distribution

  • 04548190163380 ()


  • Dental composite resin
Primer 1B
TOKUYAMA DENTAL CORPORATION
16337
In Commercial Distribution

  • 04548190163373 ()


  • Dental composite resin
Primer 1A
TOKUYAMA DENTAL CORPORATION
16336
In Commercial Distribution

  • 04548190163366 ()


  • Dental composite resin
Paste Ivory
TOKUYAMA DENTAL CORPORATION
16312
In Commercial Distribution

  • 04548190163120 ()


  • Dental composite resin
Kit Ivory
TOKUYAMA DENTAL CORPORATION
16307
In Commercial Distribution

  • 04548190163076 ()


  • Dental composite resin
Kit Clear
TOKUYAMA DENTAL CORPORATION
16306
In Commercial Distribution

  • 04548190163069 ()


  • Dental composite resin
PASTE WHITE OPAQUE
TOKUYAMA DENTAL CORPORATION
16188
In Commercial Distribution

  • 04548190161881 ()


  • Dental composite resin
PASTE CLEAR
TOKUYAMA DENTAL CORPORATION
16168
In Commercial Distribution

  • 04548190161683 ()


  • Dental composite resin
Bond A
TOKUYAMA DENTAL CORPORATION
15213
In Commercial Distribution

  • 04548190152131 ()


  • Dentine bonding agent/set
Mini Kit
TOKUYAMA DENTAL CORPORATION
15209
In Commercial Distribution

  • 04548190152094 ()


  • Dentine bonding agent/set
Kit
TOKUYAMA DENTAL CORPORATION
15203
In Commercial Distribution

  • 04548190152032 ()


  • Dentine bonding agent/set
Mini-kit
TOKUYAMA DENTAL CORPORATION
15141
In Commercial Distribution

  • 04548190151417 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
Refill
TOKUYAMA DENTAL CORPORATION
15121
In Commercial Distribution

  • 04548190151219 ()


  • Dental coating, tooth-desensitizing
  • Dental cavity varnish
Kit
TOKUYAMA DENTAL CORPORATION
15111
In Commercial Distribution

  • 04548190151110 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing
MIni kit
TOKUYAMA DENTAL CORPORATION
14992
In Commercial Distribution

  • 04548190149926 ()


  • Dentine adhesive
Pen, Twin Pen
TOKUYAMA DENTAL CORPORATION
14942
In Commercial Distribution

  • 04548190149421 ()
  • 94548190149370 ()


  • Dentine adhesive
Refill
TOKUYAMA DENTAL CORPORATION
14932
In Commercial Distribution

  • 04548190149322 ()


  • Dentine adhesive
Bonding Agent B
TOKUYAMA DENTAL CORPORATION
14737
In Commercial Distribution

  • 04548190147373 ()


  • Dentine adhesive
Kit
TOKUYAMA DENTAL CORPORATION
14706
In Commercial Distribution

  • 04548190147069 ()


  • Dentine adhesive
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vials each of level 1 & 2.
STRECK, INC.
240411
In Commercial Distribution

  • 00844509002192 ()

  • Total Volume: 3.0 Milliliter
240411

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.
STRECK, INC.
240408
In Commercial Distribution

  • 00844509002185 ()

  • Total Volume: 3.0 Milliliter
240408

  • Erythrocyte sedimentation rate (ESR) IVD, control
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213465
In Commercial Distribution

  • 00844509001997 ()

  • Total Volume: 45 Milliliter
213465

  • Urine sediment IVD, control
Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213396
In Commercial Distribution

  • 00844509001966 ()

  • Total Volume: 120 Milliliter
213396

  • Urine sediment IVD, control
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
STRECK, INC.
218991
In Commercial Distribution

  • 00844509001935 ()

  • Total Volume: 120 Milliliter
218991

  • Urine sediment IVD, control
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