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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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J-Clasp oblique - J01810211

J-Clasp oblique Ø 0.9 mm, 10 pieces in pairs (5 left and 5 right)
Scheu-Dental GmbH
1021.1
In Commercial Distribution

  • J01810210 ()
  • J01810211 ()


  • Orthodontic wire

J-Clasp oblique - J01810201

J-Clasp oblique Ø 0.8 mm, 10 pieces in pairs (5 left and 5 right)
Scheu-Dental GmbH
1020.1
In Commercial Distribution

  • J01810201 ()
  • J01810200 ()


  • Orthodontic wire

J-Clasp oblique - J01810481

J-Clasp oblique Ø 1.1 mm, 10 pieces in pairs (5 left and 5 right)
Scheu-Dental GmbH
1048.1
In Commercial Distribution

  • J01810480 ()
  • J01810481 ()


  • Orthodontic wire

CediTEC - E22160821

Luting of prefabricated prosthetic teeth in denture basis, repair and extension of dental prosthesis
VOCO GmbH
6082
In Commercial Distribution

  • E22160821 ()
6082

  • Denture reliner, hard

FORENDO PASTE - D701FORE2

CALCIUM HYDROXIDE WITH IODOFORM IN SILICON OIL BASE 2.2 gm syringe + 20 applicator tips
PULPDENT CORPORATION
FORE
In Commercial Distribution

  • D701FORE2 ()


  • Endodontic filling/sealing material

CAMINO® - 10381780023630

INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT
INTEGRA LIFESCIENCES CORPORATION
110-4BT
Not in Commercial Distribution

  • M2711104BT1 ()
  • 10381780023630 ()

  • 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
110-4BT

  • Intracerebral sensor catheter, short-term

CAMINO® - 10381780023623

OLM INTRACRANIAL PRESSURE MONITORING KIT
INTEGRA LIFESCIENCES CORPORATION
110-4B
Not in Commercial Distribution

  • 10381780023623 ()
  • M2711104B04 ()

  • 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
110-4B

  • Intracerebral sensor catheter, short-term

Bend A Brush - D798BT2501

Bend A Brushes are intended for use in the application of dental resins, sealants and etchants to the tooth surface. This is the tip option that fits in a Brush Handle.
RELIANCE ORTHODONTIC PRODUCTS INC
BT250
In Commercial Distribution

  • D798BT2501 ()
  • D798BT2500 ()
BT250

  • Dental material application tool, single-use

STELLUX® Chemi Human C-peptide ELISA Lab Pack - B24280CPTHUCH050

The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CPTHU-CH05
In Commercial Distribution

  • B24280CPTHUCH050 ()
80-CPTHU-CH05

  • C-peptide IVD, kit, chemiluminescent immunoassay

STELLUX® Chemi Human C-peptide ELISA - B24280CPTHUCH010

The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
80-CPTHU-CH01
In Commercial Distribution

  • B24280CPTHUCH010 ()
80-CPTHU-CH01

  • C-peptide IVD, kit, chemiluminescent immunoassay
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