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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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INVASIVE ACCESSORIES AND INSTRUMENTS - D821680FA25

REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant.
RHEIN 83 SRL
CLAW REAMER BUR 1 u.
Not in Commercial Distribution

  • D821680FA25 ()
680FA25

  • Dental implant holding endpiece, reusable

INVASIVE ACCESSORIES AND INSTRUMENTS - D821680FA17

REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant.
RHEIN 83 SRL
CLAW REAMER BUR 1 u.
Not in Commercial Distribution

  • D821680FA17 ()
680FA17

  • Dental implant holding endpiece, reusable

OT EQUATOR-OT BRIDGE - D821SBE500

No Description
RHEIN 83 SRL
SMART BOX HOUSING 500 u.
Not in Commercial Distribution

  • D821SBE500 ()
SBE-500

  • Surgical instrument handle, non-torque-limiting

Soteria Bed Barrier - 00850045714192

No Description
Trinity Guardion, Inc.
Affinity Therapy Foot U AFTHPU-000F
In Commercial Distribution

  • 00850045714192 ()


  • Waterproof bed mattress cover, reusable

Soteria Bed Barrier - 00850045714185

No Description
Trinity Guardion, Inc.
Affinity Therapy Head U AFTHPU-000H
In Commercial Distribution

  • 00850045714185 ()


  • Waterproof bed mattress cover, reusable

URINE QC HIGH - B80001390500040

No Description
UTAK LABORATORIES, INC.
U QC HIGH V2 EL
In Commercial Distribution

  • B80001390500040 ()
  • B80001390500041 ()
  • B80001390500042 ()
  • B80001390500043 ()
  • B80001390500046 ()
  • B80001390500047 ()
  • B80001390500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

URINE QC LOW - B80001390500030

No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

BENZODIAZEPINES HIGH - B80004740000020

BENZODIAZEPINES HIGH
UTAK LABORATORIES, INC.
BENZO H U F NDRH
In Commercial Distribution

  • B80004740000021 ()
  • B80004740000020 ()
  • B80004740000022 ()
  • B80004740000023 ()
  • B80004740000026 ()
  • B80004740000027 ()
  • B80004740000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

BENZODIAZEPINES LOW - B80004740000010

BENZODIAZEPINES LOW
UTAK LABORATORIES, INC.
BENZO L U F NDRH
In Commercial Distribution

  • B80004740000011 ()
  • B80004740000010 ()
  • B80004740000012 ()
  • B80004740000013 ()
  • B80004740000016 ()
  • B80004740000017 ()
  • B80004740000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

INVASIVE ACCESSORIES AND INSTRUMENTS - 08059224001388

No Description
RHEIN 83 SRL
CLAW REAMER BUR 1 u.
In Commercial Distribution

780FL

  • Dental implant holding endpiece, reusable
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