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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No Description
ALIMED, INC.
91-4108
In Commercial Distribution

  • 00733657286250 ()
  • 00733657300420 ()
2970011663

  • Freestanding patient positioner, reusable
No Description
ALIMED, INC.
7214010
In Commercial Distribution

  • 00733657286137 ()
  • 00733657300338 ()
2970009616

  • Vulnerable patient home alert system
No Description
ALIMED, INC.
26012
In Commercial Distribution

  • 00733657277456 ()
  • 00733657299960 ()
2970000444

  • Wheelchair seat cushion
No Description
ALIMED, INC.
95-549
In Commercial Distribution

  • 00733657244670 ()
  • 00733657299601 ()
2970017537

  • Freestanding patient positioner, single-use
This is a medical device.
ARIBEX, INC.
1.013.7789
In Commercial Distribution

  • EKAV101377890 ()
1.013.7789

  • Diagnostic x-ray system generator, hand-held
ACE NEW GAUZE 1/4 X 5YDS PLAIN STR X-RAY DETECTABLE L/F 60/CA MSDS
ACE SURGICAL SUPPLY CO., INC.
34020
In Commercial Distribution

  • 00614950025589 ()
0034020

  • Gauze strip, non-antimicrobial
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
Series 1, 600 DT, Dual CA, 1150,1000, Normal 3P SA, Dual yoke, Gen 2 light x2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007862 ()
C16D4333

  • Operating room light
S1,400 DT,Dual CA, 1750,1600, (LCH 3P SA, S/yoke 3PLight),R.Shield w/910 SA, Mav
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007602 ()
C14D874R

  • Operating room light
S1,400 DT,Dual CA, 1750,1600, (LCH 9P SA, S/yoke 9PLight),R.Shield w/910 SA, Mav
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007596 ()
C14D876R

  • Operating room light
S3 300DT Sgl Dual Sgl 2x1300 1150 1000 CA 2x Sgl MH 2x 3P DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007015 ()
C33SDS54351441

  • Operating room light
S1 700 DT 1150 1000 850 Triple CA 1x 9P DY 30M 2x 3P DY 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006575 ()
C17T432533

  • Operating room light
Series 1, 400 DT, Dual CA, 1150,1000, Normal 3P SA, Dual yoke, Gen 2 light x2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006452 ()
C14D4333

  • Operating room light
Series 1 200DT 1150,1000,850 CA, Dual yoke 3P 30M, Dual yoke 9P 30M, Sgl Sony MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006353 ()
C12T43235M

  • Operating room light
S1 200DT Dual CA 1450 1300 LCH 9P Sgl yoke SL-30M LCH 3P Sgl yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006230 ()
C12D6564

  • Operating room light
S3 400 DT 2x Sgl CA 1150mm,1000mm 2x Sgl MH SA, 2x Gen 2 MH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006131 ()
C34SSB4311

  • Operating room light
Series 1, 200 DT, Dual CA, 1150,1000, Normal 3P SA, Dual yoke, Gen 2 light x2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001518 ()
C12D4333

  • Operating room light
S3 400 DT 2x Sgl CA 1000mm,850mm 2x Sgl MH SA, 2x Gen 2 MH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001112 ()
C34SSB3211

  • Operating room light
Series 3 300 DT, blank dual CA, blank 1000 mm, 850mm Normal 3P SA, dual yoke
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706000894 ()
C33BDB3231

  • Operating room light
Series 1, 300 DT, Dual CA, 1150mm, 1000mm, Gen 1, 3p sa, sgl yoke, i25, Rad
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706008494 ()
C13D43BR

  • Operating room light
S3 400DT 2x1150 1000 850 CA 2x Sgl MH 1x 3p DY SL-30M 9p DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003703 ()
C34SDS43241531

  • Operating room light
S1 200DT Dual CA 1000/850 LCH Sgl yok 9P SL30M, Sgl MH LG Conv/Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003390 ()
C12D326J

  • Operating room light
S3 300 DT 2x sgl CA 1300/1000 2x sgl MH for Sony monitor conv/intergration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003147 ()
C33BSS53NN

  • Operating room light
S1 300 DT Dual CA, 1150,1000, 3P SA Dual yk 30M, Sgl MH Barco conv/integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706002980 ()
C13D433L

  • Operating room light
S1 200DT Dual CA 1000/850 LCH 3P Sgl yok 9P SL30M, Sgl MH Sony Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706002959 ()
C12D326N

  • Operating room light
S1 500DT Dual CA 1000/850 LCH 3P Sgl yok 3P SL30M, Sgl MH Sony Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706002942 ()
C15D324N

  • Operating room light
S1 200DT Dual CA 1000/850 LCH 3P Sgl yok 3P SL30M, Sgl MH Sony Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706002935 ()
C12D324N

  • Operating room light
S1 200DT Dual CA 1000/850 LCH 3P Sgl yok 9P SL30M-A, Sgl MH Sony Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706002928 ()
C12D320N

  • Operating room light
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
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 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
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
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
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
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
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
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
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
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