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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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MECTRON - E322029900040

D4 is a scaling insert used for restorative treatments in conjunction with Mectron Scaler handpieces.
MECTRON SPA
D4
In Commercial Distribution

  • E322029900040 ()
02990004

  • Ultrasonic dental scaling/debridement system

MECTRON - E322021700020

EN2 is an endodontical dental insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
EN2
In Commercial Distribution

  • E322021700020 ()
02170002

  • Dental ultrasonic surgical system handpiece tip
  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Epic® - M595S360UD1

Universal B2/B3 Epic®-TmpT Composite in .25-gram Unit-Dose Capsules (Pkg. of 15 Capsules)
PARKELL, INC.
S360UD
Not in Commercial Distribution

  • M595S360UD1 ()
  • M595S360UD0 ()
S360UD

  • Dental composite resin

Almore Microfil Instrument - Gold - 00014081960412

Dental composite instrument, aids in gingival line restoration to shape the margin, Length 6-1/2"
HAGER WORLDWIDE, INC.
96041
Not in Commercial Distribution

  • D2489604113 ()
  • 00014081960412 ()


  • Dental wax carver

FirstBurst Urine Collection Device v2 - B714C060005850

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
2.0
In Commercial Distribution

  • B714C060005 ()
  • B714C060005850 ()
C06-0005-85

  • Non-evacuated urine specimen container IVD, no additive

FirstBurst Urine Collection Device - B714C060003200

For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
1.0
In Commercial Distribution

  • B714C060003200 ()
  • B714C060003 ()
C06-0003-20

  • Non-evacuated urine specimen container IVD, no additive

Redicare - B70901020700

First Aid Kit intended for treating minor & moderate burns in the workplace. Managed First Aid.
REDICARE LLC
Burn Kit
In Commercial Distribution

  • B70901020700 ()
0102070

  • Burn kit, medicated

Redicare - B70901020180

Resuscitation Kit in a plastic container containing masks and gloves for performing cardiopulmonary resuscitation (CPR).
REDICARE LLC
Resuscitation Kit
In Commercial Distribution

  • B70901020180 ()
0102018

  • Cardiopulmonary resuscitation kit, single-use

Pregnenolone ELISA - B652IB59107

For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).
IBL America
IB59107
In Commercial Distribution

  • B652IB59107 ()
IB59107

  • Pregnenolone IVD, kit, enzyme immunoassay (EIA)

Estrone ELISA - B652IB59105

For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).
IBL America
IB59105
In Commercial Distribution

  • B652IB59105 ()
IB59105

  • Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA)
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