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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SCHWARTZ FORCEPS STRAIGHT, DIAMONDED, CA. 7.8 N 10 X 1.7 MM, NOT FOR NEURO AND CARDIO
Gimmi GmbH
AC.1130.07
In Commercial Distribution

  • 04049047685548 ()
AC.1130.07

  • Scalp wound clip
SCHWARTZ FORCEPS STRAIGHT, SMOOTH, CA. 7.8 N 10 X 1.7 MM, NOT FOR NEURO AND CARDIO
Gimmi GmbH
AC.1130.01
In Commercial Distribution

  • 04049047675747 ()
AC.1130.01

  • Scalp wound clip
Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control
For washing of lymphocytes in the microlymphocytotoxicity test, free of Ca and Mg, not for infusion
Bio-Rad Medical Diagnostics GmbH
824035
Not in Commercial Distribution

  • 07611969953080 ()
824035

  • Cell culture medium IVD
Cal Level 3 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC910
In Commercial Distribution

  • 00817302020472 ()

  • Total Volume: 25 Milliliter
  • Kit contains 6 R1 bottles and 1 package insert
CC910

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Cal Level 2 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC909
In Commercial Distribution

  • 00817302020465 ()

  • Total Volume: 25 Milliliter
  • Kit contains 6 R1 bottles and 1 package insert
CC909

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Underpad Incontinence Disposable Maximum Non Woven Green 72/CA Not Made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
49981
In Commercial Distribution

  • 20885632397001 ()
  • 30885632397008 ()
  • 10885632397004 ()


  • Absorbent underpad, non-antimicrobial, single-use
Underpad Incontinence Disposable Maximum Non Woven Blue 40/CA Not Made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
49979
In Commercial Distribution

  • 20885632396981 ()
  • 30885632396988 ()
  • 10885632396984 ()


  • Absorbent underpad, non-antimicrobial, single-use
ECG Electrode Monitoring Foam White 5/Pack CA/1000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49992
In Commercial Distribution

  • 30885632398210 ()
  • 20885632398213 ()
  • 10885632398216 ()


  • Electrocardiographic electrode, single-use
ECG Electrode Monitoring Foam White 50/Pack CA/1000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49991
In Commercial Distribution

  • 30885632398166 ()
  • 20885632398169 ()
  • 10885632398162 ()


  • Electrocardiographic electrode, single-use
Underpad Incontinence Disposable Maximum Non Woven White 30/CA Not Made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
49980
In Commercial Distribution

  • 20885632396998 ()
  • 30885632396995 ()
  • 10885632396991 ()


  • Absorbent underpad, non-antimicrobial, single-use
5F X 13CM DOUBLE LUMEN5F X 13CM INFUSION CATHETER SETINFUSION CA WITH MINI SCALPELWITH MINI SCALP
Medical Components, Inc.
DMC2LP-5S-ID
Not in Commercial Distribution

  • 50884908147006 ()
  • 00884908147001 ()
DMC2LP-5S-ID

  • Centrally-inserted central venous catheter
4F X 13CM DOUBLE LUMEN4F X 13CM INFUSION CATHETER SETINFUSION CA WITH MINI SCALPELWITH MINI SCALP
Medical Components, Inc.
DMC2LP-313S-ID
Not in Commercial Distribution

  • 50884908146849 ()
  • 00884908146844 ()
DMC2LP-313S-ID

  • Centrally-inserted central venous catheter
Aira Purguard - Nitrile Gloves, Blue, Xsmall, 100 Ea/Bx, 10 Bx/Ca, 1000 units in total
AIRA, LLC
119130
In Commercial Distribution

  • 00810194400254 ()
  • 00810194400001 ()
  • 10810194400008 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control
No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

  • Size Test =Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211131 ()


  • Cancer antigen 125 (CA125) IVD, reagent
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211124 ()


  • Cancer antigen 19-9 (CA19-9) IVD, reagent
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700737-001
In Commercial Distribution

  • J00717007370011 ()
1700737-001

  • Surgical power tool system control unit, line-powered
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700703-001
In Commercial Distribution

  • J00717007030011 ()
1700703-001

  • Surgical power tool system control unit, line-powered
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601237-001
In Commercial Distribution

  • J00716012370011 ()


  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601138-0
In Commercial Distribution

  • J007160113801 ()
1601138-0

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601060-001
In Commercial Distribution

  • J00716010600011 ()
1601060-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601059-001
In Commercial Distribution

  • J00716010590011 ()
1601059-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600940-001
In Commercial Distribution

  • J00716009400011 ()
1600940-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed.
Bien-Air Dental SA
1600938-0
In Commercial Distribution

  • J007160093801 ()
1600938-0

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600938-001
In Commercial Distribution

  • J00716009380011 ()
1600938-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600786-001
In Commercial Distribution

  • J00716007860011 ()
1600786-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600603-001
In Commercial Distribution

  • J00716006030011 ()
1600603-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600479-001
In Commercial Distribution

  • J00716004790011 ()
1600479-001

  • Dental power tool system handpiece, remotely-driven
No Description
CELL MARQUE CORPORATION
325M-18
In Commercial Distribution

  • 00841683136347 ()


  • Cancer antigen 125 (CA125) IVD, antibody
No Description
CELL MARQUE CORPORATION
325M-17
In Commercial Distribution

  • 00841683136330 ()


  • Cancer antigen 125 (CA125) IVD, antibody
No Description
CELL MARQUE CORPORATION
325M-15
In Commercial Distribution

  • 00841683136316 ()


  • Cancer antigen 125 (CA125) IVD, antibody
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890233
In Commercial Distribution

  • 04251204326359 ()
1890233

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890232
In Commercial Distribution

  • 04251204326311 ()
1890232

  • Microbial identification mass spectrometry system IVD
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3385
In Commercial Distribution

  • 08435389820147 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3313
In Commercial Distribution

  • 08435389820116 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3311
In Commercial Distribution

  • 08435389820109 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3310
In Commercial Distribution

  • 08435389820093 ()


  • Screw endosteal dental implant, two-piece
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