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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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DIRECTVIEW CR Cassette with PQ Screen - 60889971089410

SGL 35X43CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971089410 ()
1089416

  • Digital imaging cassette/phosphor plate

CS 7600 Smart Plate - 60889971060167

50PC CS7600 SMART PLATE SIZE 4 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060167 ()
  • 00889971060165 ()
1060169

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060150

50PC CS7600 SMART PLATE SIZE 3 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060150 ()
  • 00889971060158 ()
1060151

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060143

50PC CS7600 SMART PLATE SIZE 2 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060143 ()
  • 00889971060141 ()
1060144

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060136

50PC CS7600 SMART PLATE SIZE 1 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060136 ()
  • 00889971060134 ()
1060136

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 60889971060129

50PC CS7600 SMART PLATE SIZE 0 V2 BULK
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060129 ()
  • 00889971060127 ()
1060128

  • Digital imaging storage phosphor screen

CS 7600 SLOT PANEL - 60889971044440

CS 7600 SLOT PANEL SIZE 0 ONLY
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971044440 ()
1044445

  • Dental computed radiography digital imaging scanner

CR Cassettes for Vita Systems - 60889971033741

CARESTREAM CR CASS W SCRN 8X10IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033741 ()
1033745

  • Digital imaging cassette/phosphor plate

CR Cassettes for Vita Systems - 60889971033734

CARESTREAM CR CASS W SCRN 10X12IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033734 ()
1033737

  • Digital imaging cassette/phosphor plate

CR Cassettes for Vita Systems - 60889971033727

CARESTREAM CR CASS W SCRN 14X17IN
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889971033727 ()
1033729

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Cassette with PQ Screen - 60889971031761

35X35CM CR CASS/PQ/RIGID 100MICRON
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889971031761 ()
1031764

  • Digital imaging cassette/phosphor plate

PCD, VertaPlex - 07613252018315

Precision System Kit with Short Extension Tube and HV Bone Cement
STRYKER CORPORATION
0507589000
In Commercial Distribution

  • 37613252018316 ()
  • 07613252018315 ()
0507-589-000

  • Orthopaedic cement, non-antimicrobial

CS 7600 SLOT PANEL - 60889971023711

CS 7600 SLOT PANEL SIZE 4
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023711 ()
1023712

  • Dental computed radiography digital imaging scanner

CS 7600 SLOT PANEL - 60889971023704

CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner

EV Screens - 60889971015556

EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002815

Extraoral Cass w/ LANEX REG SCR 18x24cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
Not in Commercial Distribution

  • 60889971002815 ()
1002815

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002808

Extraoral Cass w/ LANEX REG SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002808 ()
1002807

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002785

Extraoral Cass w/ EV SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002785 ()
1002781

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen

Extraoral Cassette with LANEX Regular Screens - 60889971002778

Extraoral Cass w/ LANEX REG SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002778 ()
1002773

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with LANEX Medium Screens - 60889971002747

Extraoral Cass w/ LANEX MED SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Medium Screens
In Commercial Distribution

  • 60889971002747 ()
1002740

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

Extraoral Cassette with EV Screens - 60889971002730

Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing

RVG 6100 - 60192155314162

RVG 6100 - SIZE 0 w/o USB HUB
CARESTREAM DENTAL LLC
RVG 6100
In Commercial Distribution

  • 60192155314162 ()
5314166

  • Dental digital imaging sensor, intraoral

RVG 6200 - 60192155313981

RVG 6200 #1 FOR USE W. RVG CONNECT
CARESTREAM DENTAL LLC
RVG 6200
In Commercial Distribution

  • 60192155313981 ()
5313986

  • Dental digital imaging sensor, intraoral

RVG 5200 - 60192155311307

RVG 5200 SIZE 2
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311307 ()
5311303

  • Dental digital imaging sensor, intraoral

RVG 5200 - 60192155311291

RVG 5200 SIZE 1
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311291 ()
5311295

  • Dental digital imaging sensor, intraoral

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

Memory Staple - B56217624WB0

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

  • B56217624WB0 ()


  • Orthopaedic bone staple, non-adjustable

Affinity™ Heavy Body FS Mega Mix 380ml - 07540172000147

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013385
In Commercial Distribution

  • 07540172000147 ()

  • Total Volume: 380 Milliliter
  • cartridge
013385

  • Silicone dental impression material

Affinity™ Heavy Body RS Mega Mix 380ml - 07540172000130

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013380
In Commercial Distribution

  • 07540172000130 ()

  • Total Volume: 380 Milliliter
  • cartridge
013380

  • Silicone dental impression material

Affinity™ Inflex FS Mega Mix 380ml - 07540172000048

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

Affinity™ Inflex RS Mega Mix 380ml - 07540172000031

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

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
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