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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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Acu-Flow™ Light Body Plus - 07540172018791

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016406
Not in Commercial Distribution

  • 07540172018791 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 07540172018784

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016405
Not in Commercial Distribution

  • 07540172018784 ()

  • 2 x 300mL Jar
  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material

Acu-Flow™ Bite Registration - 07540172018777

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016399
Not in Commercial Distribution

  • 07540172018777 ()

  • 1 x 50mL Cartridge
  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material

Acu-Flow™ Best-Bite Bite Registration - 07540172018760

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016397
Not in Commercial Distribution

  • 07540172018760 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016397

  • Silicone dental impression material

Affinity ™ Heavy Body FS 120ml 2pk - 07540172012409

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
023406
In Commercial Distribution

  • 07540172012409 ()

  • Total Volume: 120 Milliliter
  • 2x120ml cartridge
023406

  • Silicone dental impression material

Affinity ™ Heavy Body RS 120ml 2pk - 07540172012393

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
023401
In Commercial Distribution

  • 07540172012393 ()

  • Total Volume: 120 Milliliter
  • 2x120ml cartridge
023401

  • Silicone dental impression material

Affinity ™ Inflex FS 120ml 2pk - 07540172012386

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
022406
In Commercial Distribution

  • 07540172012386 ()

  • Total Volume: 120 Milliliter
  • 2x120ml cartridge
022406

  • Silicone dental impression material

Affinity ™ Inflex RS 120ml Cartridge - 07540172012324

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012401
In Commercial Distribution

  • 07540172012324 ()

  • Total Volume: 120 Milliliter
  • cartridge
012401

  • Silicone dental impression material

ROM Plus® Strip Quality Control - 00814247020468

ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QCS
In Commercial Distribution

  • 20814247020462 ()
  • 10814247020465 ()
  • 00814247020468 ()


  • Amniotic fluid leak detection device IVD

ROM Plus® Quality Control Kit - 00814247020451

ROM Plus®, Quality Control for Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-QC
In Commercial Distribution

  • 20814247020455 ()
  • 10814247020458 ()
  • 00814247020451 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Collection Kit - 00814247020444

ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-6000
In Commercial Distribution

  • 20814247020448 ()
  • 10814247020441 ()
  • 00814247020444 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020437

ROM Plus® Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-5025
In Commercial Distribution

  • 10814247020434 ()
  • 00814247020437 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020420

ROM Plus® Complete Test Kit
CLINICAL INNOVATIONS, LLC
ROM-5000
In Commercial Distribution

  • 20814247020424 ()
  • 10814247020427 ()
  • 00814247020420 ()


  • Amniotic fluid leak detection device IVD

ROM Plus®, Fetal Membranes Rupture Test - 00814247020406

ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC
ROM-1025
In Commercial Distribution

  • 00814247020406 ()
  • 10814247020403 ()
  • 20814247020400 ()


  • Amniotic fluid leak detection device IVD

Auto-Cure Activator - 07290115052886

No Description
B.J.M. LABORATORIES LTD
100060
In Commercial Distribution

  • 07290115052886 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

Porcelain Etch - 07290115050479

No Description
B.J.M. LABORATORIES LTD
400082
In Commercial Distribution

  • 07290115050479 ()

  • Total Volume: 2.4 Milliliter


  • Dental prosthesis priming agent

Porcelain Silane - 07290115050462

No Description
B.J.M. LABORATORIES LTD
400083
In Commercial Distribution

  • 07290115050462 ()

  • Total Volume: 4 Milliliter


  • Dental prosthesis priming agent

Porcelain Fix - 07290115050448

Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
B.J.M. LABORATORIES LTD
400084
In Commercial Distribution

  • 07290115050448 ()

  • 2 Syringes 1.2ml (1.3g) Porcelain Etch, 2 Bottles 2ml (1.6g) Porcelain Silane


  • Dental prosthesis priming agent

High-Q-Bond Adhesive Resin Cement Automix - 07290115050370

No Description
B.J.M. LABORATORIES LTD
100050AM
In Commercial Distribution

  • 07290115050370 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin

Multi Bond - 07290115050158

No Description
B.J.M. LABORATORIES LTD
100047
In Commercial Distribution

  • 07290115050158 ()

  • Total Volume: 2 Milliliter


  • Dentine bonding agent/set

Multi Bond - 07290115050141

No Description
B.J.M. LABORATORIES LTD
100046
In Commercial Distribution

  • 07290115050141 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set

SEPTODONT CIMPAT S 4 - 7.5GM SYR KIT - 10303620001417

No Description
SEPTODONT, INC
01E0130
In Commercial Distribution

  • 10303620001417 ()

  • Weight: 7.5 Gram


  • Orthodontic bracket adhesive

CARDINAL HEALTH - 20885380168557

DISPETTE 2 PLUGGED WESTERGREN
Cardinal Health 200, LLC
B4515-9
In Commercial Distribution

  • 50885380168558 ()
  • 20885380168557 ()
  • 10885380168550 ()
B4515-9

  • Erythrocyte sedimentation rate (ESR) IVD, kit

SNAP™ - 00810000528233

SNAP™ Intro Kit (1-Liquid & 4-Powders) with Russian Labeling (Kraftway)
PARKELL, INC.
S424-R
In Commercial Distribution

  • 00810000528233 ()
S424-R

  • Temporary dental crown/bridge resin

MucoHard™ - 00810000525690

MucoHard™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard

MucoHard™ - 00810000525683

MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard

MucoHard™ - 00810000525676

MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard

E.T.C.™ - 00810000525331

E.T.C.™ Easy Temporary Cement
PARKELL, INC.
S255
In Commercial Distribution

  • 00810000525331 ()
S255

  • Dentine bonding agent/set

MucoHard™ - 00810000525270

MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • 00810000525270 ()
S487

  • Denture reliner, hard

MucoHard™ - 00810000525263

MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
S486
Not in Commercial Distribution

  • 00810000525263 ()
S486

  • Denture reliner, hard
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