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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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Renamel® Microfill - EDEL6071A50

Renamel® Microfill Enamel Body A5, Syringe 4g
DeltaMed GmbH
6071A5
In Commercial Distribution

6071A5

  • Dental composite resin

Renamel® Microfill - EDEL6071A30

Renamel® Microfill Enamel Body A3, Syringe 4g
DeltaMed GmbH
6071A3
In Commercial Distribution

6071A3

  • Dental composite resin

Renamel® Microfill - EDEL6071A10

Renamel® Microfill Enamel Body A1, Syringe 4g
DeltaMed GmbH
6071A1
In Commercial Distribution

6071A1

  • Dental composite resin

Renamel® Microhybrid - EDEL606MWO0

Renamel® Microhybrid Milky White Occlusal, Syringe 5g
DeltaMed GmbH
606MWO
In Commercial Distribution

606MWO

  • Dental composite resin

Renamel® Microhybrid - EDEL606A350

Renamel® Microhybrid Body A3.5; Syringe 5g
DeltaMed GmbH
606A35
In Commercial Distribution

606A35

  • Dental composite resin

Renamel® Microhybrid - EDEL6062LI1

Renamel® Microhybrid Light Incisal, 10 Compules
DeltaMed GmbH
6062LI
In Commercial Distribution

  • EDEL6062LI0 ()
  • EDEL6062LI1 ()
  • D7796062LI1 ()
6062LI

  • Dental composite resin

Renamel® Microhybrid - EDEL6062D41

Renamel® Microhybrid Body D4, 10 Compules
DeltaMed GmbH
6062D4
In Commercial Distribution

  • EDEL6062D40 ()
  • EDEL6062D41 ()
  • D7796062D41 ()
6062D4

  • Dental composite resin

Renamel® Microhybrid - EDEL6061A10

Renamel® Microhybrid Body A1, Syringe 5g
DeltaMed GmbH
6061A1
In Commercial Distribution

6061A1

  • Dental composite resin

Insure® Lite Automix - EDEL605ACL0

Insure® Lite Automix, Syringe 8g
DeltaMed GmbH
605ACL
In Commercial Distribution

605ACL

  • Dental composite resin

Insure® Lite - EDEL6051060

Insure® Lite Yellow Opaque, Syringe 3g
DeltaMed GmbH
605106
Not in Commercial Distribution

605106

  • Dental composite resin

Insure® Lite - EDEL6051030

Insure® Lite Yellow-Red Universal, Syringe 3g
DeltaMed GmbH
605103
Not in Commercial Distribution

605103

  • Dental composite resin

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

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

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

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

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

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

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

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

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
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