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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COM PLACM INST DE #50 TIN STD
NORDENT MANUFACTURING INC
PFI50T
In Commercial Distribution

  • 00840018635982 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #8A DL-R HDL
NORDENT MANUFACTURING INC
REPFI8A
In Commercial Distribution

  • 00840018635487 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE WOODSN #3 ST
NORDENT MANUFACTURING INC
PFIW3
In Commercial Distribution

  • 00840018635173 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE WOODSN #2 ST
NORDENT MANUFACTURING INC
PFIW2
In Commercial Distribution

  • 00840018635166 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE WOODSN #1 ST
NORDENT MANUFACTURING INC
PFIW1
In Commercial Distribution

  • 00840018635159 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE CRVD LR STD
NORDENT MANUFACTURING INC
PFILR
In Commercial Distribution

  • 00840018635135 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE GREGG #4-5 S
NORDENT MANUFACTURING INC
PFIG4-5
In Commercial Distribution

  • 00840018635104 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #8A STD HDL
NORDENT MANUFACTURING INC
PFI8A
In Commercial Distribution

  • 00840018635012 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST CP2 #6 STD HDL
NORDENT MANUFACTURING INC
PFI6
In Commercial Distribution

  • 00840018634985 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #5 STD HDL
NORDENT MANUFACTURING INC
PFI5
In Commercial Distribution

  • 00840018634978 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #4 STD HDL
NORDENT MANUFACTURING INC
PFI4
In Commercial Distribution

  • 00840018634930 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #3 STD HDL
NORDENT MANUFACTURING INC
PFI3
In Commercial Distribution

  • 00840018634893 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #20 STD HNDL
NORDENT MANUFACTURING INC
PFI20
In Commercial Distribution

  • 00840018634862 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #2 STD HDL
NORDENT MANUFACTURING INC
PFI2
In Commercial Distribution

  • 00840018634855 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #1 STD HDL
NORDENT MANUFACTURING INC
PFI1
In Commercial Distribution

  • 00840018634794 ()


  • Margin finishing dental file/rasp, reusable
SBFLCP-CO COM RA (M) FL CUP 25P
Peter Brasseler Holdings, LLC
5028343S0
In Commercial Distribution

  • 00887919878339 ()


  • Dental abrasive point, reusable
RECL DLX CL CR PVT ARM COM
GF HEALTH PRODUCTS, INC.
IN601P-COM
In Commercial Distribution

  • M368IN601PCOM1 ()


  • Reclining chair
THC PLUS
UTAK LABORATORIES, INC.
THC+ V2 S WSLH
In Commercial Distribution

  • B800THCV2SWSLH5 ()
  • B800THCV2SWSLH0 ()

  • Total Volume: 3 Milliliter
THC+ V2 S WSLH

  • Multiple drugs of abuse IVD, control
THC QC
UTAK LABORATORIES, INC.
THC QC U F NJSTL
In Commercial Distribution

  • B800THCQCUFNJSTL5 ()
  • B800THCQCUFNJSTL0 ()

  • Total Volume: 4 Milliliter
THC QC U F NJSTL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC POS
UTAK LABORATORIES, INC.
POS-205-2U
In Commercial Distribution

  • B800POS2052U5 ()
  • B800POS2052U0 ()

  • Total Volume: 2 Milliliter
POS-205-2U

  • Multiple-type clinical chemistry analyte profile IVD, control
THC (Cannabinoid)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-410A
In Commercial Distribution

  • 00817302021745 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Lateral flow immunoassay for the detection of Marijuana (THC) in urine.
GERMAINE LABORATORIES, INC
45125
In Commercial Distribution

  • 00695684451257 ()
  • 00695684451251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Quest Diagnostics
K040257
Not in Commercial Distribution

  • 00868586000247 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The Randox Cannabinoid Calibrator Set is intended for use in the calibration of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay.
RANDOX LABORATORIES LIMITED
DA2700
In Commercial Distribution

  • 05055273207842 ()
DA2700

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
DEL SYS DCS-C4-18F-US COM 26/29/31 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-US
Not in Commercial Distribution

  • 00643169565623 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
50PSI PRST COM AIR GAS REG CGA346 MRI
OHIO MEDICAL, LLC
GR-346-DCXX-XXM
In Commercial Distribution

  • 00628101618247 ()
GR-346-DCXX-XXM

  • Non-fixed medical gas cylinder regulator
909 P37,Z4,2L,1LD,AUDIO & COM SWAP,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-990-353
In Commercial Distribution

  • 00840828100359 ()
178

  • Electrical mains power extension cable
COM PLACEM INST DE, #40-30 TIN, DL HNDL
NORDENT MANUFACTURING INC
REPFI40T-30T
In Commercial Distribution

  • 00840018647244 ()


  • Margin finishing dental file/rasp, reusable
Hose 1ea, Com cable 1ea (1 set box)
DAESUNG MAREF CO.,LTD.
1000860
In Commercial Distribution

  • 18809315679814 ()
  • 08809315679817 ()
  • 28809315679811 ()


  • Hand/wrist continuous passive motion exerciser
MTO LEFT HEART KIT SAN ANGELO COM MED
MEDLINE INDUSTRIES, INC.
60010991
In Commercial Distribution

  • 20193489040439 ()
  • 10193489040432 ()
60010991

  • Angiography kit
MTO LEFT HEART KIT SEVEN RIVERS COM HOSP
MEDLINE INDUSTRIES, INC.
65193662
In Commercial Distribution

  • 10193489063233 ()
65193662

  • Angiography kit
MTO LEFT HEART KIT PARMA COM GEN HOSP
MEDLINE INDUSTRIES, INC.
651621415
In Commercial Distribution

  • 10193489076363 ()
651621415

  • Angiography kit
MTO LEFT HEART W/DT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
650305414
In Commercial Distribution

  • 10193489075151 ()
650305414

  • Angiography kit
MTO 3 WAY MANIFOLD KIT PARMA COM GEN
MEDLINE INDUSTRIES, INC.
601621410
In Commercial Distribution

  • 20193489071884 ()
  • 10193489071887 ()
601621410

  • Angiography kit
COM PLACE INST DE LR 2 TIN DL-
NORDENT MANUFACTURING INC
REPFILR2T
In Commercial Distribution

  • 00840018637689 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #5 TIN STD H
NORDENT MANUFACTURING INC
PFI5T
In Commercial Distribution

  • 00840018636002 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #4 TIN STD H
NORDENT MANUFACTURING INC
PFI4T
In Commercial Distribution

  • 00840018635975 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #3 TIN STD H
NORDENT MANUFACTURING INC
PFI3T
In Commercial Distribution

  • 00840018635937 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #2 TIN STD H
NORDENT MANUFACTURING INC
PFI2T
In Commercial Distribution

  • 00840018635883 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE #1 TIN STD H
NORDENT MANUFACTURING INC
PFI1T
In Commercial Distribution

  • 00840018635814 ()


  • Margin finishing dental file/rasp, reusable
STATION,WIRELESS READY,PULLCORD,BLUE ACT,COM,CONN
Crest Healthcare Supply
116648
In Commercial Distribution

  • B4841166480 ()


  • Nurse call system
ABVISER AV IAP COM W/ARGON T'DUCER, POLE
CONVATEC, PURCHASING DEPARTMENT
420760
Not in Commercial Distribution

  • 00768455127993 ()
  • 00768455128136 ()
420760

  • Intra-abdominal pressure measurement set, electronic
PANEL 1 THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020004
In Commercial Distribution

  • 10858904006102 ()
  • 00858904006105 ()
DTH-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC LEVEL 2
UTAK LABORATORIES, INC.
THC U 2 F PG
In Commercial Distribution

  • B800THCU2FPG5 ()
  • B800THCU2FPG0 ()

  • Total Volume: 2 Milliliter
THC U 2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 1
UTAK LABORATORIES, INC.
THC U 1 F PG
In Commercial Distribution

  • B800THCU1FPG5 ()
  • B800THCU1FPG0 ()

  • Total Volume: 2 Milliliter
THC U 1 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
THC CONTROL 3
UTAK LABORATORIES, INC.
THC QC 3 U F WDH
In Commercial Distribution

  • B800THCQC3UFWDH5 ()
  • B800THCQC3UFWDH0 ()

  • Total Volume: 10 Milliliter
THC QC 3 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 4
UTAK LABORATORIES, INC.
THC 4 U F WDH
In Commercial Distribution

  • B800THC4UFWDH5 ()
  • B800THC4UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 4 U F WDH

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

  • B800THC2UFWDH5 ()
  • B800THC2UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 2 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 1
UTAK LABORATORIES, INC.
THC 1 U F WDH
In Commercial Distribution

  • B800THC1UFWDH5 ()
  • B800THC1UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 1 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 12
UTAK LABORATORIES, INC.
THC 12 U F WDH
In Commercial Distribution

  • B800THC12UFWDH5 ()
  • B800THC12UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 12 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
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