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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Blister of 6 units
NUSMILE, LTD.
ZKFLEX3125
In Commercial Distribution

  • 00810118100673 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2525
In Commercial Distribution

  • 00810118100598 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2125
In Commercial Distribution

  • 00810118100512 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE3125
In Commercial Distribution

  • 00810118100420 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2525
In Commercial Distribution

  • 00810118100307 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2125
In Commercial Distribution

  • 00810118100185 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
25+® FINESSE® Flex Loop DSP
Alcon Laboratories, Inc.
338.25P
In Commercial Distribution

  • 17612717071442 ()
  • 07612717071445 ()


  • Epiretinal/inner limiting membrane scraper, single-use
25+® REVOLUTION DSP Serrated Forceps
Alcon Laboratories, Inc.
705.47P
In Commercial Distribution

  • 17612717071145 ()
  • 07612717071148 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
25+® REVOLUTION DSP Curved Scissors
Alcon Laboratories, Inc.
705.52P
In Commercial Distribution

  • 17612717070698 ()
  • 07612717070691 ()


  • Intraocular scissors, probe-like, single-use
25+® REVOLUTION DSP Asymmetrical Forceps
Alcon Laboratories, Inc.
705.45P
In Commercial Distribution

  • 17612717070681 ()
  • 07612717070684 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
25+® REVOLUTION DSP Endgrasping Forceps
Alcon Laboratories, Inc.
705.43P
In Commercial Distribution

  • 17612717070674 ()
  • 07612717070677 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
25+® REVOLUTION DSP ILM Forceps
Alcon Laboratories, Inc.
705.44P
In Commercial Distribution

  • 17612717070629 ()
  • 07612717070622 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
No Description
Roche Diagnostics GmbH
09634622160
In Commercial Distribution

  • 07613336232149 ()
09634622160

  • Multiple steroid hormone IVD, kit, mass spectrometry
No Description
BISCO INC.
X-80251P
Not in Commercial Distribution

  • D757X80251P1 ()

  • sixe text
X-80251P

  • Dental material application tool, single-use
No Description
COSMEDENT, INC.
203105
In Commercial Distribution

  • S77920310515 ()


  • Dental material injection cannula, reusable
GL - SINGLE THICKNESS (25)
Great Lakes Dental Technologies, Ltd.
260-034
In Commercial Distribution

  • D7752600341 ()
260-034

  • Bite registration rim wax, plate
GL - TAPERED WAFER (25)
Great Lakes Dental Technologies, Ltd.
260-032
In Commercial Distribution

  • D7752600321 ()
260-032

  • Bite registration rim wax, plate
Tips for SIROLaser Advance Plus, Sculpt IQ
SIRONA Dental Systems GmbH
6659291
In Commercial Distribution

  • E2766716562 ()
  • E27666592912 ()


  • Dental diode laser system
Endo Tips for SIROLaser Advance Plus, 25 pcs. Sculpt IQ
SIRONA Dental Systems GmbH
6659283
In Commercial Distribution

  • E27666599600 ()
  • E27666592832 ()


  • Dental diode laser system
Endo Tips for SIROLaser Blue
SIRONA Dental Systems GmbH
6535905
In Commercial Distribution

  • E27665358890 ()
  • E27665359052 ()


  • Dental diode laser system
Tips for SIROLaser Blue, 25 pcs.
SIRONA Dental Systems GmbH
6498484
In Commercial Distribution

  • E27664984680 ()
  • E27664984842 ()


  • Dental diode laser system
Tips for SiroLaser Blue, 25 pcs.
SIRONA Dental Systems GmbH
6498062
In Commercial Distribution

  • E27664980622 ()
  • E27664979650 ()


  • Dental diode laser system
Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50
MEDIMPEX UNITED, INC
DOA-12C
In Commercial Distribution

  • 10864040000348 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50
MEDIMPEX UNITED, INC
DOA-11Ca
In Commercial Distribution

  • 10864040000331 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Qtest 7 (25 Pack) - AMP 1000, BZD 300, COC 300, MET 1000, OPI 2000, OXY 100, THC 50
MEDIMPEX UNITED, INC
DOA-7QT
In Commercial Distribution

  • 10864040000324 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50
MEDIMPEX UNITED, INC
QT-CUP
In Commercial Distribution

  • 10864040000317 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
C
In Commercial Distribution

  • 10810190015534 ()
500753st

  • Suturing unit, single-use
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190015435 ()
400105st

  • Arthroscopic obturator
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
C
In Commercial Distribution

  • 10810190015541 ()
500754st

  • Suturing unit, single-use
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 10810190013264 ()
PF1-0077

  • Dental implant system
MaxSupport 25, carbon fiber, red, neutral position
MACROMEDICS B.V.
HS25
In Commercial Distribution

  • 08719425700830 ()
117125

  • Indexed-immobilization patient positioning system
Module
NOVASTEP
ACC1001P0010
Not in Commercial Distribution

  • 03700879505879 ()
ACC1001P0010

  • Device sterilization/disinfection container, reusable
GHB 25 UG/M
UTAK LABORATORIES, INC.
GHB 25 U NJSP
In Commercial Distribution

  • B800GHB25UNJSP5 ()
  • B800GHB25UNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 25 U NJSP

  • Multiple drugs of abuse IVD, control
ETHANOL 25 MG/DL
UTAK LABORATORIES, INC.
ETH 25 U 2PT ML
In Commercial Distribution

  • B800ETH25U2PTML5 ()
  • B800ETH25U2PTML0 ()

  • Total Volume: 5 Milliliter
ETH 25 U 2PT ML

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_05 25
UTAK LABORATORIES, INC.
COMP TOX I_05 25
In Commercial Distribution

  • B800COMPTOXI05255 ()
  • B800COMPTOXI05250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_05 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_04 25
UTAK LABORATORIES, INC.
COMP TOX I_04 25
In Commercial Distribution

  • B800COMPTOXI04255 ()
  • B800COMPTOXI04250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_04 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_03 25
UTAK LABORATORIES, INC.
COMP TOX I_03 25
In Commercial Distribution

  • B800COMPTOXI03255 ()
  • B800COMPTOXI03250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_03 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_02 25
UTAK LABORATORIES, INC.
COMP TOX I_02 25
In Commercial Distribution

  • B800COMPTOXI02255 ()
  • B800COMPTOXI02250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_02 25

  • Multiple-type clinical chemistry analyte profile IVD, control
COMP TOX I_01 25
UTAK LABORATORIES, INC.
COMP TOX I_01 25
In Commercial Distribution

  • B800COMPTOXI01255 ()
  • B800COMPTOXI01250 ()

  • Total Volume: 1 Milliliter
COMP TOX I_01 25

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
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