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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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230V/50HZ STD OXYGEN CONCENTRATOR -- INDIA PLUG
NIDEK MEDICAL PRODUCTS, INC.
920NI
In Commercial Distribution

  • 00038214000097 ()
920NI

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR
NIDEK MEDICAL PRODUCTS, INC.
935
In Commercial Distribution

  • 00038214000080 ()
935

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR - UK PLUG
NIDEK MEDICAL PRODUCTS, INC.
935UK
In Commercial Distribution

  • 00038214000073 ()
935UK

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR - ISRAELI PLUG
NIDEK MEDICAL PRODUCTS, INC.
925-IS
In Commercial Distribution

  • 00038214000066 ()
925-IS

  • Stationary oxygen concentrator
230V/50HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG
NIDEK MEDICAL PRODUCTS, INC.
925
In Commercial Distribution

  • 00038214000035 ()
925

  • Stationary oxygen concentrator
230V/ 50HZ STD OXYGEN CONCENTRATOR - EURO PLUG
NIDEK MEDICAL PRODUCTS, INC.
920
In Commercial Distribution

  • 00038214000028 ()
920

  • Stationary oxygen concentrator
MALU Axle, Pk/5
ALLESEE AOA-PRO
MATER21
In Commercial Distribution

  • 10889989083283 ()
  • 00889989083286 ()


  • Orthodontic clasp, metal, custom-made
AdvanSync Extender, Pk/5
ALLESEE AOA-PRO
MATER201
In Commercial Distribution

  • 10889989083191 ()
  • 00889989083194 ()


  • Orthodontic clasp, metal, custom-made
No Description
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5454
In Commercial Distribution

  • 00047400700420 ()
  • 10047400700427 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5145
In Commercial Distribution

  • 10069055890650 ()
  • 00069055890653 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL3121
In Commercial Distribution

  • 10069055890537 ()
  • 00069055890530 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5157
In Commercial Distribution

  • 10069055890520 ()
  • 00069055890523 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5147
In Commercial Distribution

  • 10069055890513 ()
  • 00069055890516 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5347
In Commercial Distribution

  • 10069055890506 ()
  • 00069055890509 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5014
Not in Commercial Distribution

  • 10069055886363 ()
  • 00069055886366 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5137
In Commercial Distribution

  • 00069055886359 ()
  • 10069055886356 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
PL5117
Not in Commercial Distribution

  • 10069055886349 ()
  • 00069055886342 ()


  • Home-use intense pulsed light hair removal unit
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
BD5004
In Commercial Distribution

  • 00069055886199 ()
  • 10069055886196 ()


  • Cosmetic red-light phototherapy system, home-use
Light Based Over-The-Counter Hair Removal
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
BD5007
In Commercial Distribution

  • 10069055880958 ()
  • 00069055880951 ()


  • Cosmetic red-light phototherapy system, home-use
Coil for E-scan XQ
ESAOTE SPA
9102206000
In Commercial Distribution

  • 08056304453310 ()


  • MRI system coil, radio-frequency
5BD acrylic baseplate
MEDTEC, INC.
105021
In Commercial Distribution

  • 00841439100189 ()
105021

  • Patient positioner base plate
No Description
HYPHEN BIOMED
221205
In Commercial Distribution

  • 03663537008238 ()
221205

  • Protein C IVD, kit, chromogenic
Chrome-plated air/water syringe
HAGER WORLDWIDE, INC.
BOA124P1000
Not in Commercial Distribution

  • 00014081124104 ()


  • Dental delivery system irrigation handpiece tip
Content: 1 piece Height: 25 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9625
In Commercial Distribution

  • D800MEAL9625 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 19 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9619
In Commercial Distribution

  • D800MEAL9619 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 17 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9617
In Commercial Distribution

  • D800MEAL9617 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 15 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9615
In Commercial Distribution

  • D800MEAL9615 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 13 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9613
In Commercial Distribution

  • D800MEAL9613 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 11 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of specific metal structures. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL9611
In Commercial Distribution

  • D800MEAL9611 ()


  • Dental bridge, metal-ceramic
No Description
Great Lakes Dental Technologies, Ltd.
047-005
In Commercial Distribution

  • D7750470050 ()


  • Dental prosthesis restorative material, unfilled resin
No Description
Great Lakes Dental Technologies, Ltd.
047-002
In Commercial Distribution

  • D7750470020 ()


  • Dental prosthesis restorative material, unfilled resin
No Description
COSMEDENT, INC.
402658
In Commercial Distribution

  • D7734026581 ()


  • Dental abrasive disk, single-use
No Description
COSMEDENT, INC.
401658
In Commercial Distribution

  • D7794016581 ()


  • Dental abrasive disk, single-use
No Description
COSMEDENT, INC.
401458
In Commercial Distribution

  • D7794014581 ()


  • Dental abrasive disk, single-use
No Description
COSMEDENT, INC.
401358
In Commercial Distribution

  • D7794013581 ()


  • Dental abrasive disk, single-use
No Description
COSMEDENT, INC.
401258
In Commercial Distribution

  • D7794012581 ()


  • Dental abrasive disk, single-use
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
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
Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte 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
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