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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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CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-211
In Commercial Distribution

  • D801ID50211I1 ()
50-211

  • Dental composite resin
CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-210
In Commercial Distribution

  • D801ID50210I1 ()
50-210

  • Dental composite resin
Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent
DISPETTE 2 SALINE
Guest Scientific AG
FH1600
Not in Commercial Distribution

  • 07612964013311 ()
  • 07612964013304 ()
  • 07612964013342 ()
FH1600

  • Erythrocyte sedimentation rate (ESR) IVD, kit
DISPETTE 2 CITRATE
Guest Scientific AG
FH1650
Not in Commercial Distribution

  • 07612964000809 ()
  • 07612964000762 ()
  • 07612964000786 ()
FH1650

  • Erythrocyte sedimentation rate (ESR) IVD, kit
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
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
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
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
CS 7600 SLOT PANEL SIZE 4
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023711 ()
1023712

  • Dental computed radiography digital imaging scanner
CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner
EV SCR, 20PR 15x30cm-Panoramic
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889971015556 ()
1015551

  • X-ray intensifying screen
Extraoral Cass w/ LANEX REG SCR 18x24cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
Not in Commercial Distribution

  • 60889971002815 ()
1002815

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen
Extraoral Cass w/ LANEX REG SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002808 ()
1002807

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
Extraoral Cass w/ EV SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002785 ()
1002781

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen
Extraoral Cass w/ LANEX REG SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Regular Screens
In Commercial Distribution

  • 60889971002778 ()
1002773

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
Extraoral Cass w/ LANEX MED SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with LANEX Medium Screens
In Commercial Distribution

  • 60889971002747 ()
1002740

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
RVG 6100 - SIZE 0 w/o USB HUB
CARESTREAM DENTAL LLC
RVG 6100
In Commercial Distribution

  • 60192155314162 ()
5314166

  • Dental digital imaging sensor, intraoral
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 SIZE 2
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311307 ()
5311303

  • Dental digital imaging sensor, intraoral
RVG 5200 SIZE 1
CARESTREAM DENTAL LLC
RVG 5200
In Commercial Distribution

  • 60192155311291 ()
5311295

  • Dental digital imaging sensor, intraoral
EV SCR 1PR 8x10in NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978997329 ()
8997322

  • X-ray intensifying screen
CARESTREAM CR Cassette 25x30/10x12
CARESTREAM HEALTH, INC.
CR Cassettes for Vita Systems
In Commercial Distribution

  • 60889978964390 ()
8964397

  • Digital imaging cassette/phosphor plate
SGL 35X35CM DIRECTVIEW PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978933884 ()
8933889

  • Digital imaging cassette/phosphor plate
24X30CM CR MAMMO SCR EHR-M3
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
In Commercial Distribution

  • 60889978869848 ()
8869844

  • Digital imaging cassette/storage phosphor screen, mammographic
35x43CM DV CR REPLACMT PLATE/PQ SCR
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with PQ Screen
In Commercial Distribution

  • 60889978824601 ()
8824609

  • Digital imaging cassette/phosphor plate
LANEX Regular SCR 20PR 4.88x14.75in H-G
CARESTREAM HEALTH, INC.
LANEX Regular Screens
In Commercial Distribution

  • 60889978802098 ()
  • 00889978802096 ()
8802092

  • X-ray intensifying screen
EV SCR 1PR 15x30cm NF
CARESTREAM HEALTH, INC.
EV Screens
In Commercial Distribution

  • 60889978793457 ()
8793457

  • X-ray intensifying screen
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