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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S1 500DT Dual CA 1300 1150 9P DY SL-30M Sgl MH for Sony monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003444 ()
C15D545M

  • Operating room light
S1 300DT Dual CA 1150 1000 9P DY SL-30M Sgl MH for Barco monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003437 ()
C13D435K

  • Operating room light
S3 300DT 2x Sgl CA 1300/1450 2xSgl MH for Sony Monitor cover/integration
Amico Clinical Solutions Corp
iCE25/iCE25
In Commercial Distribution

  • 00684706003154 ()
C33BSS56NN

  • Operating room light
S3 400 DT BLNK DUAL SGL CA 1150,1000,1300 2X3P DY SL-30M 1X SGL MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001778 ()
C34BDS435331

  • Operating room light
S3 400DT sgl Trpl blnk CA 1150,1000,850,700 2x Sgl MH 1x3P SL-30M 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001594 ()
C34STB43211351

  • Operating room light
S1 200DT Dual CA 1150 1000 3p dual yok SL-30M 9p dual yok SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001525 ()
C12D4335

  • Operating room light
S1 700DT Dual CA 1150 1000 3p dual yok SL-30M 9p dual yok SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001341 ()
C17D4335

  • Operating room light
S1 300DT Dual CA 1150 1000CA Gen 1 3P dual yoke i30, Gen2 MH
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706001136 ()
C13D43E1

  • Operating room light
Series 1 400DT Triple CA 1000/850/700 2x Dual yoke 30M Sngl MH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001006 ()
C14T321331

  • Operating room light
Series 1, 600 DT, Single CA, 850mm, sgl monitor SA, Gen 1 monitor holder
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706000887 ()
C16S21

  • Operating room light
ACCUTHRIVE DEBRIDEBLADE WOUND CARE BLADE SS STERILE USA 400BL/CA (50BL/CT, 8CT/CS)
AccuTec, Inc.
Debridement Blade
In Commercial Distribution

  • 00843382114343 ()
  • 00843382114336 ()
  • 00843382114350 ()
AVSC-3000-0000

  • Skin biopsy blade
Flight Latch Type Head Contra Angle Push Button Internal Spray (For CA Burs 2.35)
Flight Dental Systems
F-L68HEAD
In Commercial Distribution

  • D884FL68HEAD1 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Flight Latch Type Head Contra Angle Push Button External Spray (For CA Burs 2.35)
Flight Dental Systems
FFB-HEAD
In Commercial Distribution

  • D884FFBHEAD1 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
DRIVER TIP FOR TRUFIX BONE SCREWS 1.25MM SPLINE CA 19TL TI 6AL 4V ELI
ACE SURGICAL SUPPLY CO., INC.
45415201
In Commercial Distribution

  • 00614950031443 ()
45415201

  • Orthopaedic implant driver
NOVA CONTROL 1,2 Na+,K+,Cl-,Ca++,TCO2,GLU,BUN,TCa,Mg++,Li+,pH
NOVA BIOMEDICAL CORPORATION
1
In Commercial Distribution

  • 00385480186551 ()
  • 00385489186552 ()
18655

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
SUCTION TUBE CLEAR 3' STERILE 1/4"ID X 3' L/F 20/CA
ACE SURGICAL SUPPLY CO., INC.
0034238
In Commercial Distribution

  • 00614950012947 ()

  • Length: 3 Feet
0034238

  • Suction/irrigation tubing, single-use
CUSTOM SUCTION TUBE CLEAR 10' NS 1/4" X 10' L/F 25/CA
ACE SURGICAL SUPPLY CO., INC.
0034237B
In Commercial Distribution

  • 00614950012930 ()

  • Length: 10 Feet
0034237B

  • Suction/irrigation tubing, single-use
SUCTION TUBE CLEAR 10' NS 1/4"ID X 10' L/F 25/CA
ACE SURGICAL SUPPLY CO., INC.
0034237
In Commercial Distribution

  • 00614950012923 ()

  • Length: 10 Feet
0034237

  • Suction/irrigation tubing, single-use
SUCTION TUBE CLEAR 6' NS 1/4"ID X 6' L/F 25/CA
ACE SURGICAL SUPPLY CO., INC.
0034236
In Commercial Distribution

  • 00614950012916 ()

  • Length: 6 Feet
0034236

  • Suction/irrigation tubing, single-use
SUCTION TUBE CLEAR 3' NS 1/4"ID X 3' L/F 50/CA
ACE SURGICAL SUPPLY CO., INC.
0034235
In Commercial Distribution

  • 00614950012909 ()

  • Length: 3 Feet
0034235

  • Suction/irrigation tubing, single-use
3.25MM FLAT BTM FIN DRILL CA 30TL 11.5CL II TI NITRIDE BLUE MARK: 8,10,11.5
ACE SURGICAL SUPPLY CO., INC.
04968201
In Commercial Distribution

  • 00614950010653 ()
04968201

  • Fluted surgical drill bit, reusable
5.4HD FLAT BTM FIN DRILL CA 31TL 11.5CL II TI NITRIDE RED MARKINGS: 8,10,11.5
ACE SURGICAL SUPPLY CO., INC.
04959201
In Commercial Distribution

  • 00614950010561 ()
04959201

  • Fluted surgical drill bit, reusable
4.35HD FLAT BTM FIN DRILL CA 34TL 15CL II TI NITRIDE GOLD MARKINGS: 8,10,11.5,13,15
ACE SURGICAL SUPPLY CO., INC.
04958701
In Commercial Distribution

  • 00614950010530 ()
04958701

  • Fluted surgical drill bit, reusable
2.8HD FLAT BTM FIN DRILL CA 37TL 18CL II TI NITRIDE GREEN MARKINGS: 8,10,11.5,13,15,18
ACE SURGICAL SUPPLY CO., INC.
04958401
In Commercial Distribution

  • 00614950010509 ()
04958401

  • Fluted surgical drill bit, reusable
3.3MM FLAT BTM FIN DRILL CA 37TL 18CL II TI NITRIDE BLUE MARKINGS: 8,10,11.5,13,15,18
ACE SURGICAL SUPPLY CO., INC.
04958201
In Commercial Distribution

  • 00614950010493 ()
04958201

  • Fluted surgical drill bit, reusable
5mm 32cm Fenestrated Clamp, Cross Serrated, Double Action, 40mm Jaw Length, Rotating, SimpleCLICK Ca
Surgical Direct, Inc.
SD1343832-87
In Commercial Distribution

  • B382SD1343832870 ()
SD1343832-87

  • Flexible endoscopic tissue manipulation forceps, single-use
To provide calibration points for the Na+, K+, CI+, Ca++, pH, and hematocrit electrodes.
Diamond Diagnostics Inc.
CD-104227D
In Commercial Distribution

  • 00811403010325 ()
  • 00811403013036 ()


  • Multiple electrolyte IVD, calibrator
Rigid Container Sterilization 3x2x3.5 Paper CA/250 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58164
In Commercial Distribution

  • 10885632436086 ()
  • 20885632436083 ()


  • Sterilization container filter, single-use
Rigid Container Sterilization 28x9x9 Paper CA/500 Not made with Natural Rubber Latex Medichoice
OWENS & MINOR DISTRIBUTION, INC.
58158
In Commercial Distribution

  • 10885632436048 ()
  • 20885632436045 ()


  • Sterilization container filter, single-use
Foam Positioner Extremity Arm Protectors CA/20 Not Made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
49978
In Commercial Distribution

  • 30885632394007 ()
  • 20885632394000 ()
  • 10885632394003 ()


  • Freestanding patient positioner, single-use
CANNULA,ADULT SOFT,UP TO 15LPM,CURVED PRONGS,7' KINK RESIST TUBING 50/CA
BOUND TREE MEDICAL, LLC
301-PSC10715
In Commercial Distribution

  • 00812277038491 ()
  • 00812277037234 ()
301-PSC10715

  • Tracheostomy tube cannula, single-use
E-TYPE LOW SPEED SYSTEM 20k MOTOR W/1:1 STRAIGHT, 1:1 CA + HEAD
HANDPIECE PARTS & REPAIRS, INC.
ESH0104
In Commercial Distribution

  • 00810988031251 ()
ESH0104

  • Dental power tool system handpiece, pneumatic
Series 1, 600 DT, Single CA, 1150mm, (Normal 3P SA, Dual yoke, 3P Light
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009514 ()
C16S43

  • Operating room light
Series 1, 700 DT, Single CA, 1150mm, Gen 2 Dual M SA, Dual MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009484 ()
C17S42

  • Operating room light
Series 1, 500 DT, Single CA, 1000mm, (Normal 3P SA, Dual yoke, 3P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009477 ()
C15S33

  • Operating room light
"Series 1, 600 DT, Single CA, 1150mm, (LCH 3P SA, Single yoke, 3P Light), "
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009620 ()
C16S44

  • Operating room light
Series 1, 400 DT, Single CA, 1600mm, (LCH 3P SA, Single yoke, 3P Light)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009453 ()
C14S74

  • Operating room light
Series 1, 500 DT, Triple CA, 1600mm, 1450mm, 1300mm, (LCH 9P SA, Single yok
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009422 ()
C15T765W3R

  • Operating room light
Series 1, 500 DT, Single CA, 1000mm, (LCH 3P SA, Single yoke, 3P Light),
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009415 ()
C15S34

  • Operating room light
Aira Purguard - Nitrile Gloves, Pink, xsmall, 100/Bx, 10 Bx/Ca, 1000 Units Total
AIRA, LLC
119120
In Commercial Distribution

  • 00810194400452 ()
  • 00810194400209 ()
  • 10810194400206 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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