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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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Arthrodesis Nail System Nail, ø11mm X 150mm
Ascension Orthopedics, Inc.
PAN-1010-11150
In Commercial Distribution

  • 10381780504344 ()

  • ø11mm X 150mm
PAN-1010-11150

  • Arthrodesis intramedullary nail, non-distracting
Arthrodesis Nail System Nail, ø10mm X 240mm
Ascension Orthopedics, Inc.
PAN-1010-10240
In Commercial Distribution

  • 10381780504337 ()

  • ø10mm X 240mm
PAN-1010-10240

  • Arthrodesis intramedullary nail, non-distracting
Arthrodesis Nail System Nail, ø10mm X 210mm
Ascension Orthopedics, Inc.
PAN-1010-10210
In Commercial Distribution

  • 10381780504320 ()

  • ø10mm X 210mm
PAN-1010-10210

  • Arthrodesis intramedullary nail, non-distracting
Arthrodesis Nail System Nail, ø10mm X 180mm
Ascension Orthopedics, Inc.
PAN-1010-10180
In Commercial Distribution

  • 10381780504313 ()

  • ø10mm X 180mm
PAN-1010-10180

  • Arthrodesis intramedullary nail, non-distracting
Arthrodesis Nail System Nail, ø10mm X 150mm
Ascension Orthopedics, Inc.
PAN-1010-10150
In Commercial Distribution

  • 10381780504306 ()

  • ø10mm X 150mm
PAN-1010-10150

  • Arthrodesis intramedullary nail, non-distracting
The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized
Timpel S/A
AD-05002
In Commercial Distribution

  • 07898959841279 ()
  • 07908715700037 ()


  • Electrical impedance skin electrode chest positioner
The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized
Timpel S/A
ACE-00035
In Commercial Distribution

  • 07898966433306 ()


  • Electrical impedance skin electrode chest positioner
OSTEOTOME N 2
Sin Sistema de Implante Nacional S/A
OST 02
In Commercial Distribution

  • 07899995254481 ()
OST 02

  • Dental osteotome
ADULTERANT LEVEL 2
UTAK LABORATORIES, INC.
ADULT 2 U KP
In Commercial Distribution

  • B800ADULT2UKP5 ()
  • B800ADULT2UKP0 ()

  • Total Volume: 10 Milliliter
ADULT 2 U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
6-MONOACETYLMORPHINE LEVEL 2
UTAK LABORATORIES, INC.
6-MAM 2 OF NAVIS
In Commercial Distribution

  • B8006MAM2OFNAVIS5 ()
  • B8006MAM2OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 2 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LC 2
UTAK LABORATORIES, INC.
50703
In Commercial Distribution

  • B800507035 ()
  • B800507030 ()

  • Total Volume: 10 Milliliter
50703

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 DP UK
In Commercial Distribution

  • B80001696000041 ()
  • B80001696000040 ()
  • B80001696000042 ()
  • B80001696000043 ()
  • B80001696000046 ()
  • B80001696000047 ()
  • B80001696000048 ()


  • Multiple heavy metal IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 WB UK
In Commercial Distribution

  • B80001696000021 ()
  • B80001696000020 ()
  • B80001696000022 ()
  • B80001696000023 ()
  • B80001696000026 ()
  • B80001696000027 ()
  • B80001696000028 ()


  • Multiple heavy metal IVD, control
No Description
ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDA
302
In Commercial Distribution

  • 07898588840087 ()


  • Orthodontic pliers
AMIODARONE LEVEL 2
UTAK LABORATORIES, INC.
AMIO 2 S F QDVA
In Commercial Distribution

  • B800AMIO2SFQDVA5 ()
  • B800AMIO2SFQDVA0 ()

  • Total Volume: 5 Milliliter
AMIO 2 S F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
ALUMINUM LEVEL 2
UTAK LABORATORIES, INC.
ALUM 2 S BP
In Commercial Distribution

  • B800ALUM2SBP5 ()
  • B800ALUM2SBP0 ()

  • Total Volume: 3 Milliliter
ALUM 2 S BP

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS 2
UTAK LABORATORIES, INC.
ALP+ 2 V2 S SH
In Commercial Distribution

  • B800ALP2V2SSH0 ()

  • Total Volume: 3 Milliliter
ALP+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALDO 2 F UVHS
In Commercial Distribution

  • B800ALDO2FUVHS0 ()

  • Total Volume: 10 Milliliter
ALDO 2 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALD 2 U F LC
In Commercial Distribution

  • B800ALD2UFLC5 ()
  • B800ALD2UFLC0 ()

  • Total Volume: 5 Milliliter
ALD 2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
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