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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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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

CS 7400 - 40889978666948

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

  • 60889978666942 ()
  • 40889978666948 ()
8666943

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978645448

DIRECTVIEW CR Cassett with PQ Scrn 35x35
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978645442 ()
  • 40889978645448 ()
8645442

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978637689

DIRECTVIEW CR Grid Cass w PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
Not in Commercial Distribution

  • 60889978637683 ()
  • 40889978637689 ()
8637688

  • Digital imaging cassette/phosphor plate

Imaging Plate - 40889978610095

(2) SZ 3 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978610099 ()
  • 40889978610095 ()
  • 00889978610097 ()
8610099

  • Digital imaging storage phosphor screen

Medical X-ray Blue / MXB Film - 40889978609891

MXB FILM 8X10IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609895 ()
  • 40889978609891 ()
  • 00889978609893 ()
8609893

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609877

MXB FILM 10X12IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609871 ()
  • 40889978609877 ()
  • 00889978609879 ()
8609877

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609860

MXB FILM 11X14IN 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609864 ()
  • 40889978609860 ()
  • 00889978609862 ()
8609869

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609839

MXB FILM 35X35-14X14 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609833 ()
  • 40889978609839 ()
  • 00889978609831 ()
8609836

  • Medical x-ray film, screen

Medical X-ray Blue / MXB Film - 40889978609815

MXB FILM 35X43-14X17 100SH
CARESTREAM HEALTH, INC.
Medical X-ray Blue / MXB Film
In Commercial Distribution

  • 60889978609819 ()
  • 40889978609815 ()
  • 00889978609817 ()
8609810

  • Medical x-ray film, screen

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

DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978909885

DIRECTVIEW CR Cassett with PQ Scrn 15x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978909889 ()
  • 40889978909885 ()
8909889

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Gridded Cassette with PQ Screen - 40889978864818

DIRECTVIEW CR Cassett with PQ Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Gridded Cassette with PQ Screen
In Commercial Distribution

  • 60889978864812 ()
  • 40889978864818 ()
8864811

  • Digital imaging cassette/phosphor plate

DIRECTVIEW CR Mammography Cassette with EHR-M Screen - 40889978792128

DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Not in Commercial Distribution

  • 60889978792122 ()
  • 40889978792128 ()
8792129

  • Digital imaging cassette/storage phosphor screen, mammographic

CS 7400 - 40889978427969

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

  • 60889978427963 ()
  • 40889978427969 ()
8427965

  • Dental computed radiography digital imaging scanner

DIRECTVIEW CR Cassette with PQ Screen - 40889978413511

DIRECTVIEW CR Cassett with PQ Scrn 35x43
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978413515 ()
  • 40889978413511 ()
8413510

  • Digital imaging cassette/phosphor plate

Imaging Plate - 40889978406841

(2) SZ 1 DENTAL CR I/O IMAG PLATES
CARESTREAM HEALTH, INC.
Imaging Plate
In Commercial Distribution

  • 60889978406845 ()
  • 40889978406841 ()
  • 00889978406843 ()
8406845

  • Digital imaging storage phosphor screen

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

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

Aqueduct SED - ACCCARTV101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCARTL200

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-200L
In Commercial Distribution

  • ACCCARTL200 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCART101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101
In Commercial Distribution

  • ACCCART101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCART100

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-100
Not in Commercial Distribution

  • ACCCART100 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Auto-Cure Activator - 07290115052886

No Description
B.J.M. LABORATORIES LTD
100060
In Commercial Distribution

  • 07290115052886 ()

  • Total Volume: 10 Milliliter


  • Dentine bonding agent/set
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