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

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


  • Amniotic fluid leak detection device IVD
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
No Description
B.J.M. LABORATORIES LTD
100060
In Commercial Distribution

  • 07290115052886 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set
No Description
B.J.M. LABORATORIES LTD
400082
In Commercial Distribution

  • 07290115050479 ()

  • Total Volume: 2.4 Milliliter


  • Dental prosthesis priming agent
No Description
B.J.M. LABORATORIES LTD
400083
In Commercial Distribution

  • 07290115050462 ()

  • Total Volume: 4 Milliliter


  • Dental prosthesis priming agent
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
No Description
B.J.M. LABORATORIES LTD
100050AM
In Commercial Distribution

  • 07290115050370 ()

  • Total Volume: 5 Milliliter


  • Dental composite resin
No Description
B.J.M. LABORATORIES LTD
100047
In Commercial Distribution

  • 07290115050158 ()

  • Total Volume: 2 Milliliter


  • Dentine bonding agent/set
No Description
B.J.M. LABORATORIES LTD
100046
In Commercial Distribution

  • 07290115050141 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set
No Description
SEPTODONT, INC
01E0130
In Commercial Distribution

  • 10303620001417 ()

  • Weight: 7.5 Gram


  • Orthodontic bracket adhesive
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™ 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™+ Primer Refill
PARKELL, INC.
S642
In Commercial Distribution

  • 00810000525690 ()
S642

  • Denture reliner, hard
MucoHard™+ Cartridge Refill
PARKELL, INC.
S641
In Commercial Distribution

  • 00810000525683 ()
S641

  • Denture reliner, hard
MucoHard™+ Kit
PARKELL, INC.
S640
In Commercial Distribution

  • 00810000525676 ()
S640

  • Denture reliner, hard
E.T.C.™ Easy Temporary Cement
PARKELL, INC.
S255
In Commercial Distribution

  • 00810000525331 ()
S255

  • Dentine bonding agent/set
MucoHard™ Hard Denture Reline Kit
PARKELL, INC.
S487
Not in Commercial Distribution

  • 00810000525270 ()
S487

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

  • 00810000525263 ()
S486

  • Denture reliner, hard
MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes
PARKELL, INC.
S485
Not in Commercial Distribution

  • 00810000525256 ()
S485

  • Denture reliner, hard
All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating
DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating
CS3500 SMALL TIP (5 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Small Tip
In Commercial Distribution

  • 60889976567883 ()
  • 00889976567881 ()
6567887

  • Dental milling system, CAD/CAM, chairside
CS3500 COLLAR PACKING (10 PIECES)
CARESTREAM HEALTH, INC.
CS 3500 3D Scanner Collar
In Commercial Distribution

  • 60889976567876 ()
  • 00889976567874 ()
6567879

  • Dental milling system, CAD/CAM, chairside
LANEX Medium SCR 20PR 8x10in NF
CARESTREAM HEALTH, INC.
LANEX Medium Screens
In Commercial Distribution

  • 60889971997654 ()
  • 00889971997652 ()
1997659

  • X-ray intensifying screen
CARESTREAM CR Cassette 35x43 / 14x17
CARESTREAM HEALTH, INC.
CARESTREAM CR Mammography Cassette with SNP-M1 Screen
In Commercial Distribution

  • 60889971978608 ()
1978600

  • Digital imaging cassette/storage phosphor screen, mammographic
Point-of-Care CR Cass W SCRN TYP A 25x30
CARESTREAM HEALTH, INC.
Point-of-Care CR Cassette with Screen Type A
In Commercial Distribution

  • 60889971880758 ()
1880756

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

  • 60889971831989 ()
1831981

  • Digital imaging cassette/phosphor plate
18x24CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971827296 ()
1827294

  • Digital imaging cassette/phosphor plate
X-OMATIC Regular SCR, 1PR 5x12in NF
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889971820884 ()
1820885

  • X-ray intensifying screen
EV SCR 1PR 4.88x14.75in hinged
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971791177 ()
1791177

  • X-ray intensifying screen
LANEX Regular SCR 20PR 8x10in NF
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971717740 ()
  • 00889971717748 ()
1717743

  • X-ray intensifying screen
10SC 18X24CM ESCN HR PHOSPHOR SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
In Commercial Distribution

  • 60889971717443 ()
  • 00889971717441 ()
1717446

  • Digital imaging cassette/storage phosphor screen, mammographic
CARESTREAM CR Cassette 35x83/14x33
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971696830 ()
1696830

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Cassett with HR Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
Not in Commercial Distribution

  • 60889971650511 ()
1650514

  • Digital imaging cassette/storage phosphor screen, mammographic
35x35CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971640987 ()
1640986

  • Digital imaging cassette/phosphor plate
CARESTREAM CR Cassette 15x30 cm
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971627582 ()
1627587

  • Digital imaging cassette/phosphor plate
X-OMATIC Regular SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
X-OMATIC Regular Screens
In Commercial Distribution

  • 60889971604019 ()
1604016

  • X-ray intensifying screen
35X43CM CR CASS/PQ/RIGID 100MICRON
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971603241 ()
1603240

  • Digital imaging cassette/phosphor plate
10SC 24X30CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971600004 ()
  • 00889971600002 ()
1600006

  • Digital imaging cassette/phosphor plate
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