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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 Mammography Cassette with EHR-M3 Screen - 40889978336193

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 Screen GP-2 - 40889978271067

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

CS 7400 - 40889978214231

CR SEMI-FIN PLATE PAN V2 5X12IN
CARESTREAM HEALTH, INC.
CS 7400
In Commercial Distribution

  • 60889978214235 ()
  • 40889978214231 ()
8214231

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889978188341

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

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 40889978156180

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 - 40889978145429

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 Screens - 40889971976204

LANEX Regular SCR 1PR 13x18cm
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889971976208 ()
  • 40889971976204 ()
1976208

  • X-ray intensifying screen

CARESTREAM CR Mammography Cassette with SNP-M1 Screen - 40889971941509

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

DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen - 40889971790312

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

Imaging Plate - 40889971683379

(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

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971667577

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 Gridded Cassette with PQ Screen - 40889971585215

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

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889971508276

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

Imaging Plate - 40889971435404

CR SEMI-FIN PLATE CEPH 8X10IN
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889971435408 ()
  • 40889971435404 ()
1435403

  • Digital imaging storage phosphor screen

Flexible Phosphor Screen GP-2 - 40889971423166

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

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 - 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 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 - 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 - 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

Automatrix Snippers+ Catch Tray - D010624226051

Automatrix Snippers+ Catch Tray is a part of the Automatrix Snippers+ to prevent clipped loop pieces rom the oral cavity.
Dentsply De Trey GmbH
62422605
In Commercial Distribution

  • D010624226050 ()
  • D010624226051 ()

  • Length: 1.9 Centimeter
62422605

  • Orthodontic pliers

PCD, VertaPlex - 07613327357851

Precision System with Extension Tube and HV Bone Cement
STRYKER CORPORATION
0507586000
In Commercial Distribution

  • 37613327357852 ()
  • 07613327357851 ()

  • Angle: 90.0 degree
0507-586-000

  • Orthopaedic cement, non-antimicrobial

SEPTODONT ADHERENCE REF SYR OPAQUE 4GM - 00303620000567

No Description
SEPTODONT, INC
01C2010
In Commercial Distribution

  • 00303620000567 ()

  • Weight: 4 Gram


  • Multi-purpose soft contact lens solution

SmartLite Focus - D010644500701

SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp

Mixint Tip / Intraoral Tip - D01060620111

Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material

Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit - 00359883005672

Gingival Retraction Solution
DEN-MAT HOLDINGS, LLC
641960
In Commercial Distribution

  • 00359883005672 ()

  • Total Volume: 60 Milliliter
641960

  • Gingival retraction solution

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
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