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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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MucoHard™ - 00810000525263

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

  • 00810000525263 ()
S486

  • Denture reliner, hard

MucoHard™ - 00810000525256

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

  • 00810000525256 ()
S485

  • Denture reliner, hard

DuraFinish™ - 00810000525195

All-Cure DuraFinish™ Composite Glaze
PARKELL, INC.
S296
In Commercial Distribution

  • 00810000525195 ()
S296

  • Dental unfilled resin sealant/coating

DuraFinish™ - 00810000525188

DuraFinish™ Composite Glaze
PARKELL, INC.
S295
Not in Commercial Distribution

  • 00810000525188 ()
S295

  • Dental unfilled resin sealant/coating

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

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

LANEX Regular Screens - 40889971414683

LANEX Regular SCR 1PR 5x12in NF
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971414687 ()
  • 40889971414683 ()
1414689

  • X-ray intensifying screen

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971342863

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

Imaging Plate - 40889971340074

(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

CS 7400 - 40889971337227

CR SEMI-FIN PLATE PAN V2 15X30CM
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889971337221 ()
  • 40889971337227 ()
1337229

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971290386

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 Cassette with HR Screen - 40889971269672

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

Imaging Plate - 40889971067568

Imaging Plate #2 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067562 ()
  • 40889971067568 ()
  • 00889971067560 ()
1067560

  • Digital imaging storage phosphor screen

Imaging Plate - 40889971067551

Imaging Plate #1 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067555 ()
  • 40889971067551 ()
  • 00889971067553 ()
1067552

  • Digital imaging storage phosphor screen

Imaging Plate - 40889971067544

Imaging Plate #0 - 4 Pcs
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971067548 ()
  • 40889971067544 ()
  • 00889971067546 ()
1067545

  • Digital imaging storage phosphor screen

CS 7200 - 40889971067513

Hygienic Sheaths #2 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067517 ()
  • 40889971067513 ()
  • 00889971067515 ()
1067511

  • Dental computed radiography digital imaging scanner

CS 7200 - 40889971067506

Hygienic Sheaths #1 - 200 Pcs
CARESTREAM HEALTH, INC.
CS 7200
In Commercial Distribution

  • 60889971067500 ()
  • 40889971067506 ()
  • 00889971067508 ()
1067503

  • Dental computed radiography digital imaging scanner

Hygienic Sheaths - 40889971067490

Hygienic Sheaths #0 - 200 Pcs
CARESTREAM HEALTH, INC.
Hygienic Sheaths
In Commercial Distribution

  • 60889971067494 ()
  • 40889971067490 ()
  • 00889971067492 ()
1067495

  • Cable/lead/sensor/probe cover, sterile

CS 7600 Smart Plate - 40889971060019

CS7600 SMART PLATE SIZE 4 V2 - 2 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971060013 ()
  • 40889971060019 ()
  • 00889971060011 ()
1060011

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059990

CS7600 SMART PLATE SIZE 3 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059994 ()
  • 40889971059990 ()
  • 00889971059992 ()
1059997

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059983

CS7600 SMART PLATE SIZE 2 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059987 ()
  • 40889971059983 ()
  • 00889971059985 ()
1059989

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059969

CS7600 SMART PLATE SIZE 1 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059963 ()
  • 40889971059969 ()
  • 00889971059961 ()
1059963

  • Digital imaging storage phosphor screen

LANEX Regular Screens - 40889971207377

LANEX Regular SCR 1PR 8x10in
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971207371 ()
  • 40889971207377 ()
1207372

  • X-ray intensifying screen

Imaging Plate - 40889971098913

CR SEMI-FIN PLATE CEPH 18X24CM
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971098917 ()
  • 40889971098913 ()
1098912

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971059952

CS7600 SMART PLATE SIZE 0 V2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
In Commercial Distribution

  • 60889971059956 ()
  • 40889971059952 ()
  • 00889971059954 ()
1059955

  • Digital imaging storage phosphor screen

DIRECTVIEW CR Cassette with HR Screen - 40889971044613

18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate

Full Blue X-ray Film WB - 40889971031712

100SH 35X43-14X17 BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
In Commercial Distribution

  • 60889971031716 ()
  • 40889971031712 ()
  • 00889971031714 ()
1031715

  • Medical x-ray film, screen

CS 7600 Smart Plate - 40889971014463

CS 7600 SMART PLATE SIZE 4 - 2 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
Not in Commercial Distribution

  • 60889971014467 ()
  • 40889971014463 ()
  • 00889971014465 ()
1014463

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971014456

CS 7600 SMART PLATE SIZE 3 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
Not in Commercial Distribution

  • 60889971014450 ()
  • 40889971014456 ()
  • 00889971014458 ()
1014455

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971014449

CS 7600 SMART PLATE SIZE 2 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
Not in Commercial Distribution

  • 60889971014443 ()
  • 40889971014449 ()
  • 00889971014441 ()
1014448

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971014432

CS 7600 SMART PLATE SIZE 1 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
Not in Commercial Distribution

  • 60889971014436 ()
  • 40889971014432 ()
  • 00889971014434 ()
1014430

  • Digital imaging storage phosphor screen

CS 7600 Smart Plate - 40889971014425

CS 7600 SMART PLATE SIZE 0 - 4 PCS
CARESTREAM HEALTH, INC.
CS 7600 Smart Plate
Not in Commercial Distribution

  • 60889971014429 ()
  • 40889971014425 ()
  • 00889971014427 ()
1014422

  • Digital imaging storage phosphor screen

CS 7600 Hygienic Sheath - 40889971014401

CS 7600 HYG SHEATHS SIZE 4 200 PCS
CARESTREAM HEALTH, INC.
CS 7600 Hygienic Sheath
In Commercial Distribution

  • 60889971014405 ()
  • 40889971014401 ()
  • 00889971014403 ()
1014406

  • Cable/lead/sensor/probe cover, sterile

CS 7600 Hygienic Sheath - 40889971014395

CS 7600 HYG SHEATHS SIZE 3 200 PCS
CARESTREAM HEALTH, INC.
CS 7600 Hygienic Sheath
In Commercial Distribution

  • 60889971014399 ()
  • 40889971014395 ()
  • 00889971014397 ()
1014398

  • Cable/lead/sensor/probe cover, sterile
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