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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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Multi-Analyte DAU Calibrator Set B, Intermediate Calibrator - B07608340

15mL/bottle. Concentration of Multi-Analyte: 750 ng/mL MDMA, 4000 ng/mL morphine, 500 ng/mL oxazepam, and 500 ng/mL secobarbital.
LIN-ZHI INTERNATIONAL, INC.
0834
In Commercial Distribution

  • B07608340 ()
0834

  • Multiple drugs of abuse IVD, calibrator

Multi-Analyte DAU Calibrator Set B, Cutoff Calibrator - B07608330

15mL/bottle. Concentration of Multi-Analyte: 500 ng/mL MDMA, 2000 ng/mL morphine, 200 ng/mL oxazepam, and 200 ng/mL secobarbital.
LIN-ZHI INTERNATIONAL, INC.
0833
In Commercial Distribution

  • B07608330 ()
0833

  • Multiple drugs of abuse IVD, calibrator

Multi-Analyte DAU Calibrator Set B, Low Calibrator - B07608320

15mL/bottle. Concentration of Multi-Analyte: 250 ng/mL MDMA, 1000 ng/mL morphine, 100 ng/mL oxazepam, and 100 ng/mL secobarbital.
LIN-ZHI INTERNATIONAL, INC.
0832
In Commercial Distribution

  • B07608320 ()
0832

  • Multiple drugs of abuse IVD, calibrator

Bonding Agent (Self-Cure) Part A & Part B - D83610181

• Simple and fast application technique. • Compatible with all light-cured, and self-cured restorative materials and cements. • Long shelf-life with no need for refrigeration. • Economical. • No pulp irritation.
DENT ZAR, INC.
1018
In Commercial Distribution

  • D83610181 ()
1018

  • Dentine bonding agent/set

Capo Slow Flow B 3, 2 g - ESDG2320671

Capo Slow Flow is a light-curing, flowable, highly radiopaque composite with a high viscosity.
Schütz Dental GmbH
232067
In Commercial Distribution

  • ESDG2320671 ()


  • Dental composite resin

Capo Slow Flow B 2, 2 g - ESDG2320661

Capo Slow Flow is a light-curing, flowable, highly radiopaque composite with a high viscosity.
Schütz Dental GmbH
232066
In Commercial Distribution

  • ESDG2320661 ()


  • Dental composite resin

Capo Slow Flow B 1, 2 g - ESDG2320651

Capo Slow Flow is a light-curing, flowable, highly radiopaque composite with a high viscosity.
Schütz Dental GmbH
232065
In Commercial Distribution

  • ESDG2320651 ()


  • Dental composite resin

Schertl Fasszg.,gefenstert,d/b,5/330mm - EMAH26054330

Schertl grasp.fcps.,fenestr.,d/a,5/330mm
mahe medical gmbh
26.054.33
In Commercial Distribution

  • EMAH26054331 ()
  • EMAH26054330 ()
26.054.33

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

SciPharm Until Temporary Crown and Bridge Cement - D801SP55252N1

Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Part B. Non-Boxed
SCIENTIFIC PHARMACEUTICALS, INC.
SP 55-252 N
In Commercial Distribution

  • D801SP55252N1 ()
55-252

  • Glass ionomer dental cement

SciPharm Until Temporary Crown and Bridge Cement - D801SP55252B1

Until - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Part B. Boxed
SCIENTIFIC PHARMACEUTICALS, INC.
SP 55-252 B
In Commercial Distribution

  • D801SP55252B1 ()
55-252

  • Glass ionomer dental cement
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