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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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Fresco Gingiva 5 (20 g) - D800KEAD6342

Content: 20 g
ZIRKONZAHN SRL
KEAD6342
In Commercial Distribution

  • D800KEAD6342 ()


  • Dental appliance fabrication material, ceramic

Fresco Gingiva 5 (10 g) - D800KEAD63410

Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD63410 ()


  • Dental appliance fabrication material, ceramic

Fresco Gingiva 5 (10 g) - D800KEAD6341

Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD6341 ()


  • Dental appliance fabrication material, ceramic

STD ProCHO 5 Powder, 50L - 00840075403685

No Description
Lonza Walkersville, Inc.
WPW-045F
In Commercial Distribution

  • 00840075403685 ()
WPW-045F

  • Ex vivo cell culture medium

STD ProCHO 5 Powder, 10L - 00840075403678

No Description
Lonza Walkersville, Inc.
WPW-045D
In Commercial Distribution

  • 00840075403678 ()
WPW-045D

  • Ex vivo cell culture medium

5% Sucrose50mMTris,pH 7.4,2mM MgCl2,100L - 00840075402671

No Description
Lonza Walkersville, Inc.
08-735D
In Commercial Distribution

  • 00840075402671 ()
08-735D

  • Ex vivo cell culture medium

5% Sucrose50mMTris,pH 7.4,2mM MgCl2,10L - 00840075401377

No Description
Lonza Walkersville, Inc.
08-735B
In Commercial Distribution

  • 00840075401377 ()
08-735B

  • Ex vivo cell culture medium

UPPER LIMB KIT – 5 WISE - 08051122041022

The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the upper district.
NCS LAB SRL
SHWM01U5
In Commercial Distribution

  • 08051122041022 ()


  • Kinesiology/electromyographic sensor set

Ceramic Tissue 5 (100 g) - D800KEAA6242

Content: 100 g
ZIRKONZAHN SRL
KEAA6242
In Commercial Distribution

  • D800KEAA6242 ()


  • Dental appliance fabrication material, ceramic

Ceramic Tissue 5 (20 g) - D800KEAA6241

Content: 20 g Colour scale from very bright (Tissue 1) to very dark (Tissue 6)
ZIRKONZAHN SRL
KEAA6241
In Commercial Distribution

  • D800KEAA6241 ()


  • Dental appliance fabrication material, ceramic

WIRING BASE COIL N.5 - 08056304453396

Coil for Artoscan
ESAOTE SPA
9102000000
In Commercial Distribution

  • 08056304453396 ()


  • MRI system coil, radio-frequency

SERVICE SHOULDER COIL N.5 - 08056304453327

Coil for E-scan XQ
ESAOTE SPA
9102206001
In Commercial Distribution

  • 08056304453327 ()


  • MRI system coil, radio-frequency

DPA ANKLE COIL N.5 - 08056304453228

Coil for C-scan
ESAOTE SPA
9101645000
In Commercial Distribution

  • 08056304453228 ()


  • MRI system coil, radio-frequency

ampli-connect R 5 L PH - 07613389718188

No Description
Sonova AG
(velvet black)
In Commercial Distribution

  • 07613389718188 ()
050-1094-P867

  • Air-conduction hearing aid, receiver-in-canal

ampli-connect R 5 L PH - 07613389718171

No Description
Sonova AG
(silver gray)
In Commercial Distribution

  • 07613389718171 ()
050-1094-P667

  • Air-conduction hearing aid, receiver-in-canal

ampli-connect R 5 L PH - 07613389718164

No Description
Sonova AG
(sand beige)
In Commercial Distribution

  • 07613389718164 ()
050-1094-P167

  • Air-conduction hearing aid, receiver-in-canal

ampli-connect R 5 L PH - 07613389718157

No Description
Sonova AG
(beige)
In Commercial Distribution

  • 07613389718157 ()
050-1094-H067

  • Air-conduction hearing aid, receiver-in-canal

Mission Control Linearity, 5 Levels - 00811403014798

Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control

Class II Complement - 5 ml - 00812117014326

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014326 ()
CDR-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Class I Complement - 5 ml - 00812117014302

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014302 ()
CABC-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

CalSet Troponin T Gen 5 - 07613336148280

No Description
Roche Diagnostics GmbH
08250499160
In Commercial Distribution

  • 07613336148280 ()
08250499160

  • Troponin T IVD, calibrator

Elecsys Troponin T Gen 5 - 07613336148273

No Description
Roche Diagnostics GmbH
08250472160
In Commercial Distribution

  • 07613336148273 ()
08250472160

  • Troponin T IVD, kit, enzyme immunoassay (EIA)

Elecsys Troponin T Gen 5 - 07613336158982

No Description
Roche Diagnostics GmbH
08469890160
In Commercial Distribution

  • 07613336158982 ()
08469890160

  • Troponin T IVD, reagent

Elecsys Troponin T Gen 5 - 07613336158951

Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Roche Diagnostics GmbH
08469865160
In Commercial Distribution

  • 07613336158951 ()
08469865160

  • Troponin T IVD, reagent

ASSY,Reag.Disp.Card,PrepKit 5,BenchMark - 07613336125373

No Description
Ventana Medical Systems, Inc.
05251362001
In Commercial Distribution

  • 07613336125373 ()
05251362001

  • Assay container IVD, single-use

NexES Dispenser Card Fixative 5 - 07613336125137

No Description
Ventana Medical Systems, Inc.
05271665001
In Commercial Distribution

  • 07613336125137 ()
05271665001

  • Assay container IVD, single-use

NexES Dispenser Card Option 5 - 07613336125045

No Description
Ventana Medical Systems, Inc.
05271886001
In Commercial Distribution

  • 07613336125045 ()
05271886001

  • Assay container IVD, single-use

NexES Dispenser Card Enzyme 5 - 07613336124956

No Description
Ventana Medical Systems, Inc.
05271550001
In Commercial Distribution

  • 07613336124956 ()
05271550001

  • Assay container IVD, single-use

NexES Dispenser Card Counterstain 5 - 07613336124840

No Description
Ventana Medical Systems, Inc.
05271762001
In Commercial Distribution

  • 07613336124840 ()
05271762001

  • Assay container IVD, single-use

POINTE SCIENTIFIC Ammonia Standard 5 - 00811727010278

The Ammonia Standards are intended for the calibration of ammonia assays.
POINTE SCIENTIFIC, INC.
A7553-STD500
In Commercial Distribution

  • 00811727010278 ()
A7553-STD500

  • Ammonia IVD, calibrator

22" 5 Leg Stand Base - 00813830027686

22" 5 Leg Stand Base
ACCUTRON, INC.
28350-FRU
In Commercial Distribution

  • 00813830027686 ()
28350-FRU

  • Gas cylinder holder

BUSULFAN CALIBRATOR LEVEL 5 V2 - B800BUSCAL5V2DPFMDACC0

BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control

ETG PLUS CALIBRATOR LEVEL 5 - B800ETGCAL5V2UFUCSF0

ETG PLUS CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL5V2UFUCSF5 ()
  • B800ETGCAL5V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 5 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control

SERUM DRUG SCREEN LEVEL 5 - B800DS5SID0

SERUM DRUG SCREEN LEVEL 5
UTAK LABORATORIES, INC.
DS 5 S ID
In Commercial Distribution

  • B800DS5SID5 ()
  • B800DS5SID0 ()

  • Total Volume: 3 Milliliter
DS 5 S ID

  • Benzodiazepine group IVD, control

DRUGS OF ABUSE LEVEL 5 - B800DAUCAL5V3FNHI0

DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 V3 F NHI
In Commercial Distribution

  • B800DAUCAL5V3FNHI5 ()
  • B800DAUCAL5V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 5 V3 F NHI

  • Multiple drugs of abuse IVD, control

DRUGS OF ABUSE CALIBRATOR 5 - B800DAUCAL5UFNPIL0

DRUGS OF ABUSE CALIBRATOR 5
UTAK LABORATORIES, INC.
DAU CAL 5 U F NPIL
In Commercial Distribution

  • B800DAUCAL5UFNPIL5 ()
  • B800DAUCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
DAU CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control

DRUGS OF ABUSE LEVEL 5 - B800DAU5FLE0

DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU 5 F LE
In Commercial Distribution

  • B800DAU5FLE5 ()
  • B800DAU5FLE0 ()

  • Total Volume: 12 Milliliter
DAU 5 F LE

  • Multiple drugs of abuse IVD, control

VOLATILES PLUS 5 MG/DL - B800VOL5MFCL0

VOLATILES PLUS 5 MG/DL
UTAK LABORATORIES, INC.
VOL+ 5 MFCL
In Commercial Distribution

  • B800VOL5MFCL5 ()
  • B800VOL5MFCL0 ()

  • Total Volume: 3 Milliliter
VOL+ 5 MFCL

  • Multiple-type clinical chemistry analyte profile IVD, control

ISAVUCONAZOLE PLUS CALIBRATOR 5 V2 - B800ISACAL5V2SFUCSF0

ISAVUCONAZOLE PLUS CALIBRATOR 5 V2
UTAK LABORATORIES, INC.
ISA+ CAL 5 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control

Alliance Non-Cann Rmr Sz 5 - 00889024632837

No Description
Zimmer, Inc.
SSI006725
In Commercial Distribution

  • 00889024632837 ()

  • Sz 5
SSI006725

  • Bone-resection orthopaedic reamer, reusable
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