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 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
Memory Staple 30 x 30-2 x 3mm / LRG
Wishbone Medical, Inc.
17624WB
Not in Commercial Distribution

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013385
In Commercial Distribution

  • 07540172000147 ()

  • Total Volume: 380 Milliliter
  • cartridge
013385

  • Silicone dental impression material
VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013380
In Commercial Distribution

  • 07540172000130 ()

  • Total Volume: 380 Milliliter
  • cartridge
013380

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012385
In Commercial Distribution

  • 07540172000048 ()

  • Total Volume: 380 Milliliter
  • cartridge
012385

  • Silicone dental impression material
VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012380
In Commercial Distribution

  • 07540172000031 ()

  • Total Volume: 380 Milliliter
  • cartridge
012380

  • Silicone dental impression material
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
DIRECTVIEW CR Cassett with PQ Scrn 15x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978909889 ()
  • 40889978909885 ()
8909889

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Cassett with PQ Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978864812 ()
  • 40889978864818 ()
8864811

  • Digital imaging cassette/phosphor plate
DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889978792122 ()
  • 40889978792128 ()
8792129

  • Digital imaging cassette/storage phosphor screen, mammographic
CR SEMI-FIN PLATE PAN 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978666942 ()
  • 40889978666948 ()
8666943

  • Dental computed radiography digital imaging scanner
DIRECTVIEW CR Cassett with PQ Scrn 35x35
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978645442 ()
  • 40889978645448 ()
8645442

  • Digital imaging cassette/phosphor plate
DIRECTVIEW CR Grid Cass w PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
Not in Commercial Distribution

  • 60889978637683 ()
  • 40889978637689 ()
8637688

  • Digital imaging cassette/phosphor plate
(2) SZ 3 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978610099 ()
  • 40889978610095 ()
  • 00889978610097 ()
8610099

  • Digital imaging storage phosphor screen
MXB FILM 8X10IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609895 ()
  • 40889978609891 ()
  • 00889978609893 ()
8609893

  • Medical x-ray film, screen
MXB FILM 10X12IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609871 ()
  • 40889978609877 ()
  • 00889978609879 ()
8609877

  • Medical x-ray film, screen
MXB FILM 11X14IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609864 ()
  • 40889978609860 ()
  • 00889978609862 ()
8609869

  • Medical x-ray film, screen
MXB FILM 35X35-14X14 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609833 ()
  • 40889978609839 ()
  • 00889978609831 ()
8609836

  • Medical x-ray film, screen
MXB FILM 35X43-14X17 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609819 ()
  • 40889978609815 ()
  • 00889978609817 ()
8609810

  • Medical x-ray film, screen
CR SEMI-FIN PLATE PAN 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner
DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate
(2) SZ 1 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978406845 ()
  • 40889978406841 ()
  • 00889978406843 ()
8406845

  • Digital imaging storage phosphor screen
18X24CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978336197 ()
  • 40889978336193 ()
8336190

  • Digital imaging cassette/storage phosphor screen, mammographic
Flexible Phosphor Scrn GP-2 25x30/10x12
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889978271061 ()
  • 40889978271067 ()
8271066

  • Digital imaging storage phosphor screen
CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner
18X24CM DVIEW CR MAMMO SCR EHR-M
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889978188345 ()
  • 40889978188341 ()
8188344

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVW CR Mammo Cass EHR-M3 Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978156184 ()
  • 40889978156180 ()
8156184

  • Digital imaging cassette/storage phosphor screen, mammographic
FLEXIBLE PHOSPHOR SCREEN GP-2 24X30 CM
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889978145423 ()
  • 40889978145429 ()
8145427

  • Digital imaging storage phosphor screen
LANEX Regular SCR 1PR 13x18cm
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971976208 ()
  • 40889971976204 ()
1976208

  • X-ray intensifying screen
18X24 CR MAMMO CASS W/SNP-M1 SCREEN
CARESTREAM HEALTH, INC.
CARESTREAM CR Mammography Cassette with SNP-M1 Screen
In Commercial Distribution

  • 60889971941503 ()
  • 40889971941509 ()
1941509

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889971790316 ()
  • 40889971790312 ()
1790310

  • Digital imaging cassette/storage phosphor screen, mammographic
(2) SZ 4 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971683373 ()
  • 40889971683379 ()
  • 00889971683371 ()
1683374

  • Digital imaging storage phosphor screen
DIRECTVW CR Mammo Cass EHR-M2 Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889971667571 ()
  • 40889971667577 ()
1667575

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVIEW CR Cassett with PQ Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889971585219 ()
  • 40889971585215 ()
1585215

  • Digital imaging cassette/phosphor plate
DIRECTVW CR Mammo Cass EHR-M Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889971508270 ()
  • 40889971508276 ()
1508274

  • Digital imaging cassette/storage phosphor screen, mammographic
CR SEMI-FIN PLATE CEPH 8X10IN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971435408 ()
  • 40889971435404 ()
1435403

  • Digital imaging storage phosphor screen
Flexible Phosphor Scrn GP-2 35x43/14x17
CARESTREAM HEALTH, INC.
Flexible Phosphor Screen GP-2
In Commercial Distribution

  • 60889971423160 ()
  • 40889971423166 ()
1423169

  • Digital imaging storage phosphor screen
LANEX Regular SCR 1PR 5x12in NF
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971414687 ()
  • 40889971414683 ()
1414689

  • X-ray intensifying screen
18X24CM DVIEW CR MAMMO SCR EHR-M2
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
In Commercial Distribution

  • 60889971342867 ()
  • 40889971342863 ()
1342864

  • Digital imaging cassette/storage phosphor screen, mammographic
(2) SZ 2 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971340078 ()
  • 40889971340074 ()
  • 00889971340076 ()
1340074

  • Digital imaging storage phosphor screen
CR SEMI-FIN PLATE PAN V2 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889971337221 ()
  • 40889971337227 ()
1337229

  • Dental computed radiography digital imaging scanner
DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889971290380 ()
  • 40889971290386 ()
1290386

  • Digital imaging cassette/storage phosphor screen, mammographic
DIRECTVIEW CR Cassett with HR Scrn 18x24
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
Not in Commercial Distribution

  • 60889971269676 ()
  • 40889971269672 ()
1269679

  • Digital imaging cassette/phosphor plate
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