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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Rigid Container Sterilization 11.5x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58184
In Commercial Distribution

  • 10885632436239 ()


  • Instrument tray, reusable
Rigid Container Sterilization 18x11x5 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58183
In Commercial Distribution

  • 10885632436222 ()


  • Instrument tray, reusable
Rigid Container Sterilization 18x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58182
In Commercial Distribution

  • 10885632436215 ()


  • Instrument tray, reusable
Rigid Container Sterilization 18x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58181
In Commercial Distribution

  • 10885632436208 ()


  • Instrument tray, reusable
Rigid Container Sterilization 18x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58178
In Commercial Distribution

  • 10885632436192 ()


  • Instrument tray, reusable
Rigid Container Sterilization 22x11x5 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58176
In Commercial Distribution

  • 10885632436185 ()


  • Instrument tray, reusable
Rigid Container Sterilization 22x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58175
In Commercial Distribution

  • 10885632436178 ()


  • Instrument tray, reusable
Rigid Container Sterilization 22x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58174
In Commercial Distribution

  • 10885632436161 ()


  • Instrument tray, reusable
Rigid Container Sterilization 22x11x4 Stainless Steel Silver CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58173
In Commercial Distribution

  • 10885632436154 ()


  • Instrument tray, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy BLACK CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58172
In Commercial Distribution

  • 10885632436147 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy GREEN CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58171
In Commercial Distribution

  • 10885632436130 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy BLUE CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58169
In Commercial Distribution

  • 10885632436123 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy RED CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58168
In Commercial Distribution

  • 10885632436116 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy YELLOW CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58167
In Commercial Distribution

  • 10885632436109 ()


  • Device sterilization/disinfection container, reusable
Rigid Container Sterilization 3x1x1 Aluminum Alloy SILVER CA/1 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58165
In Commercial Distribution

  • 10885632436093 ()


  • Device sterilization/disinfection container, reusable
Intermittent Catheter Pedriatric 8FR 10IN PVC CLEAR CA/600 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55809
In Commercial Distribution

  • 30885632423738 ()
  • 10885632423734 ()
  • 20885632423731 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Pedriatric 14FR 10IN PVC CLEAR CA/600 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55808
In Commercial Distribution

  • 20885632423724 ()
  • 30885632423721 ()
  • 10885632423727 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Pedriatric 12FR 10IN PVC CLEAR CA/600 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55807
In Commercial Distribution

  • 20885632423717 ()
  • 30885632423714 ()
  • 10885632423710 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Pedriatric 10FR 10IN PVC CLEAR CA/600 NOT MADE WITH NATURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55806
In Commercial Distribution

  • 30885632423707 ()
  • 10885632423703 ()
  • 20885632423700 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Male Coude 18FR 16IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55793
In Commercial Distribution

  • 30885632423608 ()
  • 10885632423604 ()
  • 20885632423601 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Male Coude 16FR 16IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55791
In Commercial Distribution

  • 30885632423592 ()
  • 10885632423598 ()
  • 20885632423595 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Male Coude 14FR 16IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55789
In Commercial Distribution

  • 20885632423588 ()
  • 30885632423585 ()
  • 10885632423581 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Male Coude 12FR 16IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55788
In Commercial Distribution

  • 30885632423578 ()
  • 10885632423574 ()
  • 20885632423571 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Male Coude 10FR 16IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55786
In Commercial Distribution

  • 30885632423561 ()
  • 10885632423567 ()
  • 20885632423564 ()


  • Single-administration urethral drainage/irrigation catheter
Intermittent Catheter Female Luer 14FR 6IN PVC CLEAR CA/600 NOT MADE WITHTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
55757
In Commercial Distribution

  • 30885632423424 ()
  • 10885632423420 ()
  • 20885632423427 ()


  • Single-administration urethral drainage/irrigation catheter
INFANT TRANSPORT MATTRESS LARGE 9.65X15.75IN SODIUM ACETATE CA 6 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51795
In Commercial Distribution

  • 20885632413947 ()
  • 10885632413940 ()


  • Hot/cold therapy pack, single-use
REUSABLE GEL PACK LARGE 10X12IN GLYCERINE CA 12 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51790
In Commercial Distribution

  • 20885632413893 ()
  • 10885632413896 ()


  • Hot/cold therapy pack, reusable
Grounding Pad Split Cord Adult Multiple Green CA/100 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55552
In Commercial Distribution

  • 20885632412872 ()
  • 30885632412879 ()
  • 10885632412875 ()


  • Electrosurgical return electrode, single-use
Electrode Neonatal Prewired CA/100 Radiolucent 3 per pack Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
55549
In Commercial Distribution

  • 20885632412858 ()
  • 10885632412851 ()


  • Electrocardiographic electrode, single-use
SUCTION TUBE 6' OPAQUE NS W/ADAPT 1/4"ID X 6' L/F 25/CA
ACE SURGICAL SUPPLY CO., INC.
0034244
In Commercial Distribution

  • 00614950012992 ()

  • Length: 6 Feet
0034244

  • Suction/irrigation tubing, single-use
SUCTION TUBE 10'OPAQUE STL L/F W/ADAPTER 1/4"ID X 10' 20/CA
ACE SURGICAL SUPPLY CO., INC.
0034242
In Commercial Distribution

  • 00614950012985 ()

  • Length: 10 Feet
0034242

  • Suction/irrigation tubing, single-use
SUCTION TUBE 6' OPAQUE STERILE W/ADAPTER 1/4"ID X 6'L/F 20/CA
ACE SURGICAL SUPPLY CO., INC.
0034241
In Commercial Distribution

  • 00614950012978 ()

  • Length: 6 Feet
0034241

  • Suction/irrigation tubing, single-use
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
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
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
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
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
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
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 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
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
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
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
CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control
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
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