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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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CLIA Waived 5 Panel Drug Test Card-(THC-COC-OPI-AMP-PCP)
Medical Disposables Corp
M-DOA-154
In Commercial Distribution

  • 00851721007430 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 6 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP)
Medical Disposables Corp
M-DOA-164
In Commercial Distribution

  • 00851721007423 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine based drug testing device for Methamphetamine
PHAMATECH, INCORPORATED
9068T
In Commercial Distribution

  • 00674033090682 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Thermoplastic mouth guard - Case of 3
Grind Guard Technologies, L.L.C.
203
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000050 ()
203

  • Mouthguard, reusable
Thermoplastic mouth guard - Case of 12
Grind Guard Technologies, L.L.C.
212
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000043 ()
212

  • Mouthguard, reusable
Thermoplastic mouth guard - Case of 10
Grind Guard Technologies, L.L.C.
210
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000036 ()
210

  • Mouthguard, reusable
Dental mouth guard for clenching and grinding teeth (bruxism)
Smartguard Rx, Inc.
SGDG6
In Commercial Distribution

  • 10866330000205 ()
  • 00866330000208 ()
  • 30866330000209 ()
  • 20866330000202 ()


  • Mouthguard, reusable
Lateral flow immunoassay for the detection of Phencyclidine (PCP) in urine.
GERMAINE LABORATORIES, INC
49125
In Commercial Distribution

  • 00695684491253 ()
  • 00695684491251 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Rest Assured Mouth Guard with Tray
WAL-MART STORES, INC.
SQN
In Commercial Distribution

  • 20681131135607 ()
  • 00681131135603 ()
  • 80681131135609 ()


  • Mouthguard, reusable
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set
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