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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No Description
ALIMED, INC.
931036
In Commercial Distribution

  • 00733657239393 ()
  • 00733657299441 ()
2970013247

  • Hand/finger splint, reusable
No Description
ALIMED, INC.
931035
In Commercial Distribution

  • 00733657239386 ()
  • 00733657299434 ()
2970013246

  • Hand/finger splint, reusable
No Description
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838107502 ()


  • General-purpose ultrasound imaging system
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 3
In Commercial Distribution

  • M724400534S1 ()
400-534S

  • Nasal cartilage support implant, non-bioabsorbable
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 2
In Commercial Distribution

  • M724400524S1 ()
400-524S

  • Nasal cartilage support implant, non-bioabsorbable
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 1
In Commercial Distribution

  • M724400514S1 ()
400-514S

  • Nasal cartilage support implant, non-bioabsorbable
Nasal Implant
IMPLANTECH ASSOCIATES, INC.
Size 4
In Commercial Distribution

  • M724400544S1 ()
400-544S

  • Nasal cartilage support implant, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
414912
In Commercial Distribution

  • 00880304370333 ()
414912

  • Bone-resection orthopaedic reamer, reusable
No Description
DIAGNOSTICA STAGO
00674
In Commercial Distribution

  • 13607450006749 ()
  • 03607450006742 ()


  • Fibrinogen assay (factor I) IVD, kit, clotting
No Description
Biomet Orthopedics, LLC
595151
In Commercial Distribution

  • 00880304397149 ()
595151

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
14270
In Commercial Distribution

  • 00880304491946 ()
14270

  • Surgical torque wrench, reusable
No Description
Hangzhou Formed Medical Devices Co.Ltd.
PA150205
In Commercial Distribution

  • 06923310903530 ()
PA150205

  • Anaesthesia face mask, single-use
No Description
Longfian Scitech Co., Ltd.
SOC5100
In Commercial Distribution

  • 06934726614439 ()


  • Mobile/portable oxygen concentrator
No Description
CHARMANT INC.
24-0003
In Commercial Distribution

  • 00883475954753 ()


  • Gastrointestinal endoscopic clip applier
Tenzing 5 delivery catheter
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007619 ()


  • Thrombectomy suction catheter
  • Vascular guide-catheter, single-use
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
351
In Commercial Distribution

  • 00842430111693 ()
351

  • Traction weight
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5875-05
In Commercial Distribution

  • 00842430110252 ()
5875-05

  • Operating table torso positioner
No Description
DATASCOPE CORP.
T 50002
Not in Commercial Distribution

  • 00607567208568 ()
709000235

  • Cardiopulmonary bypass system blood tubing set
No Description
ergoline GmbH
191002.T
Not in Commercial Distribution

  • 04059358001630 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002.P
Not in Commercial Distribution

  • 04059358001623 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002
In Commercial Distribution

  • 04059358001616 ()


  • Bicycle ergometer
Sorbalgon 4x8 5/Bx
HARTMANN USA, INC.
49230001
In Commercial Distribution

  • 04052199569833 ()
  • 04052199569826 ()
  • 04052199569840 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control
CYSTATHIONINE PLUS LEVEL 5
UTAK LABORATORIES, INC.
CYST+ 5 LC
In Commercial Distribution

  • B800CYST5LC5 ()
  • B800CYST5LC0 ()

  • Total Volume: 5 Milliliter
CYST+ 5 LC

  • Multiple-type clinical chemistry analyte profile IVD, control
Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control
DAU CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 F ERSO
In Commercial Distribution

  • B800DAUCAL5FERSO5 ()
  • B800DAUCAL5FERSO0 ()

  • Total Volume: 4 Milliliter
DAU CAL 5 F ERSO

  • Multiple drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
THC PLUS LEVEL 5
UTAK LABORATORIES, INC.
THC+ 5 U F WCT
In Commercial Distribution

  • B800THC5UFWCT5 ()
  • B800THC5UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 5 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE 5 NG/M
UTAK LABORATORIES, INC.
pos-m245-1-2ml
In Commercial Distribution

  • B800POSM24512ML0 ()

  • Total Volume: 2 Milliliter
pos-m245-1-2ml

  • Multiple-therapy therapeutic drug monitoring IVD, control
PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PENTOBARBITAL 5 UG/ML
UTAK LABORATORIES, INC.
PENTO 5 JHH
In Commercial Distribution

  • B800PENTO5JHH0 ()
  • B800PENTO5JHH5 ()

  • Total Volume: 5 Milliliter
PENTO 5 JHH

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
OPI U CAL 5 UNC
In Commercial Distribution

  • B800OPIUCAL5UNC5 ()
  • B800OPIUCAL5UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 5 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
MYCOPHENOLIC ACID LEVEL 5
UTAK LABORATORIES, INC.
MPA 5 S MAYO
In Commercial Distribution

  • B800MPA5SMAYO5 ()
  • B800MPA5SMAYO0 ()

  • Total Volume: .25 Milliliter
MPA 5 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
METHOTREXATE 5 UMOL/L
UTAK LABORATORIES, INC.
METHO 5 S UPHS
In Commercial Distribution

  • B800METHO5SUPHS0 ()

  • Total Volume: 5 Milliliter
METHO 5 S UPHS

  • Multiple-type clinical chemistry analyte profile IVD, control
SAVUCONAZOLE PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ISA+ CAL 5 S F UCSF
In Commercial Distribution

  • B800ISACAL5SFUCSF5 ()
  • B800ISACAL5SFUCSF0 ()

  • Total Volume: 0.5 Milliliter
ISA+ CAL 5 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
FENT+ CAL 5 U F KP
In Commercial Distribution

  • B800FENTCAL5UFKP5 ()
  • B800FENTCAL5UFKP0 ()

  • Total Volume: 1 Milliliter
FENT+ CAL 5 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 5
UTAK LABORATORIES, INC.
FENT+ 5 U QD
In Commercial Distribution

  • B800FENT5UQD5 ()
  • B800FENT5UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 5 U QD

  • Multiple drugs of abuse IVD, control
ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-09A
In Commercial Distribution

  • 00817830021392 ()

  • Length: 75 Millimeter
07RD7064-09A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MTD / OPI
RAPID DIAGNOSTICS INC
07RD7064-09
In Commercial Distribution

  • 00817830021385 ()

  • Length: 75 Millimeter
07RD7064-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7064-08A
In Commercial Distribution

  • 00817830021378 ()

  • Length: 75 Millimeter
07RD7064-08A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-08
In Commercial Distribution

  • 00817830021361 ()

  • Length: 75 Millimeter
07RD7064-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI-II
RAPID DIAGNOSTICS INC
07RD7064-07A
In Commercial Distribution

  • 00817830021354 ()

  • Length: 75 Millimeter
07RD7064-07A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI
RAPID DIAGNOSTICS INC
07RD7064-07
In Commercial Distribution

  • 00817830021347 ()

  • Length: 75 Millimeter
07RD7064-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7064-06
In Commercial Distribution

  • 00817830021330 ()

  • Length: 75 Millimeter
07RD7064-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7064-05A
In Commercial Distribution

  • 00817830021323 ()

  • Length: 75 Millimeter
07RD7064-05A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-05
In Commercial Distribution

  • 00817830021316 ()

  • Length: 75 Millimeter
07RD7064-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7064-04A
In Commercial Distribution

  • 00817830021309 ()

  • Length: 75 Millimeter
07RD7064-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7064-04
In Commercial Distribution

  • 00817830021293 ()

  • Length: 75 Millimeter
07RD7064-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7064-03A
In Commercial Distribution

  • 00817830021286 ()

  • Length: 75 Millimeter
07RD7064-03A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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