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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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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

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

CS 7600 Hygienic Sheath - 40889971014388

CS 7600 HYG SHEATHS SIZE 2 200 PCS
CARESTREAM HEALTH, INC.
CS 7600 Hygienic Sheath
In Commercial Distribution

  • 60889971014382 ()
  • 40889971014388 ()
  • 00889971014380 ()
1014380

  • Cable/lead/sensor/probe cover, sterile

CS 7600 Hygienic Sheath - 40889971014371

CS 7600 HYG SHEATHS SIZE 1 200 PCS
CARESTREAM HEALTH, INC.
CS 7600 Hygienic Sheath
In Commercial Distribution

  • 60889971014375 ()
  • 40889971014371 ()
  • 00889971014373 ()
1014372

  • Cable/lead/sensor/probe cover, sterile

CS 7600 Hygienic Sheath - 40889971014364

CS 7600 HYG SHEATHS SIZE 0 200 PCS
CARESTREAM HEALTH, INC.
CS 7600 Hygienic Sheath
In Commercial Distribution

  • 60889971014368 ()
  • 40889971014364 ()
  • 00889971014366 ()
1014364

  • Cable/lead/sensor/probe cover, sterile

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

Acu-Flow™ Monophase - 07540172018876

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016404
Not in Commercial Distribution

  • 07540172018876 ()

  • 6 x 50mL Cartridge
  • Total Volume: 300 Milliliter
1-016404

  • Silicone dental impression material

Acu-Flow™ Rigid Tray - 07540172018869

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016403
Not in Commercial Distribution

  • 07540172018869 ()

  • 6 x 50mL Cartridge
  • Total Volume: 300 Milliliter
1-016403

  • Silicone dental impression material

Acu-Flow™ Heavy Body - 07540172018852

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016402
Not in Commercial Distribution

  • 07540172018852 ()

  • 6 x 50mL Cartridge
  • Total Volume: 300 Milliliter
1-016402

  • Silicone dental impression material

Acu-Flow™ Light Body 6pk - 07540172018845

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016401
Not in Commercial Distribution

  • 07540172018845 ()

  • 6 x 50mL Cartridge
  • Total Volume: 300 Milliliter
1-016401

  • Silicone dental impression material

Acu-Flow™ Bite Registration - 07540172018838

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016400
Not in Commercial Distribution

  • 07540172018838 ()

  • 6 x 50mL Cartridge
  • Total Volume: 300 Milliliter
1-016400

  • Silicone dental impression material

Acu-Flow™ Rigid Tray - 07540172018821

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016409
Not in Commercial Distribution

  • 07540172018821 ()

  • 1 x 50mL Cartridge
  • Total Volume: 50 Milliliter
1-016409

  • Silicone dental impression material

Acu-Flow™ Medium Body - 07540172018814

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016408
Not in Commercial Distribution

  • 07540172018814 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016408

  • Silicone dental impression material

Acu-Flow™ Heavy Body - 07540172018807

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016407
Not in Commercial Distribution

  • 07540172018807 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016407

  • Silicone dental impression material

Acu-Flow™ Light Body Plus - 07540172018791

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016406
Not in Commercial Distribution

  • 07540172018791 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016406

  • Silicone dental impression material

Acu-Flow™ Putty Kit - 07540172018784

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016405
Not in Commercial Distribution

  • 07540172018784 ()

  • 2 x 300mL Jar
  • Total Volume: 600 Milliliter
1-016405

  • Silicone dental impression material

Acu-Flow™ Bite Registration - 07540172018777

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016399
Not in Commercial Distribution

  • 07540172018777 ()

  • 1 x 50mL Cartridge
  • Total Volume: 50 Milliliter
1-016399

  • Silicone dental impression material

Acu-Flow™ Best-Bite Bite Registration - 07540172018760

Hydrophillic Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
1-016397
Not in Commercial Distribution

  • 07540172018760 ()

  • Total Volume: 50 Milliliter
  • 1 x 50mL Cartridge
1-016397

  • Silicone dental impression material

Affinity™ Heavy Body FS Mega Mix 380ml - 07540172017046

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013386
In Commercial Distribution

  • 07540172017046 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013385

  • Silicone dental impression material

Affinity™ Heavy Body RS Mega Mix 380ml - 07540172017039

VPS Impression Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
013381
In Commercial Distribution

  • 07540172017039 ()

  • Cartridge
  • Total Volume: 380 Milliliter
013380

  • Silicone dental impression material

Affinity™ Inflex RS Mega Mix 380ml - 07540172017015

VPS Impression Tray Material
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
012381
In Commercial Distribution

  • 07540172017015 ()

  • Cartridge
  • Total Volume: 380 Milliliter
012380

  • Silicone dental impression material

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

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
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