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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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OrthoMedFlex - M7161121525230

Trial Liner 20° 32/60-70 (E)
ORTHOMEDFLEX LLC
112152523
In Commercial Distribution

  • M7161121525230 ()
112-152-523

  • Acetabulum prosthesis trial, prefabricated, reusable

OrthoMedFlex - M7161111292040

Tryon (Logical) Liner, Constrained Assembly E
ORTHOMEDFLEX LLC
111129204
In Commercial Distribution

  • M7161111292040 ()
111-12-9204

  • Constrained polyethylene acetabular liner

T2Bacteria® QCheck Negative Kit - M70885080743

Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885080730

Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution

  • M70885080730 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885071910

Positive SK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-07191
In Commercial Distribution

  • M70885071910 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

Power Dental USA - D94313030

SCALERS ANTERIOR N128 S/E SINGLE END
Power Dental U.S.A. Inc.
1303
In Commercial Distribution

  • D94313030 ()
1303

  • Dental excavator, reusable
  • Manual dental scaler, reusable

Power Dental USA - D943193050

PERIOTOME POWER FLEX FPT-1 D/E DURABLE
Power Dental U.S.A. Inc.
1930-5
In Commercial Distribution

  • D943193050 ()
1930-5

  • Orthodontic pliers
  • Periotome, reusable

Power Dental USA - D943193040

PERIOTOME POWER FLEX FPT-2 D/E DURABLE
Power Dental U.S.A. Inc.
1930-4
In Commercial Distribution

  • D943193040 ()
1930-4

  • Orthodontic pliers
  • Periotome, reusable

Power Dental USA - D943193020

POWER FLEX PERIOTOME CVD S/E DURABLE
Power Dental U.S.A. Inc.
1930-2
In Commercial Distribution

  • D943193020 ()
1930-2

  • Orthodontic pliers
  • Periotome, reusable

Power Dental USA - D943193010

POWER FLEX PERIOTOME STR S/E DURABLE
Power Dental U.S.A. Inc.
1930-1
In Commercial Distribution

  • D943193010 ()
1930-1

  • Orthodontic pliers
  • Periotome, reusable
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