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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S3 400DT Sgl,Dual,Sgl CA 1150,1000,850,1150 2xSgl MH, DY 2x 3p SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001464 ()
C34SDS43241331

  • Operating room light
S1 200DT Dual CA 1150 1000 G1 9p LCH i30 G2 sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001389 ()
C12D43H1

  • Operating room light
S1 300DT Dual CA 1000 850 LCH 9P SL-30M Gen 2 Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001242 ()
C13D3261

  • Operating room light
S3 400DT Sgl/Dbl CA 1150/1000/1150 Gen 2 sgl MH, 2xSL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001099 ()
C34SDB434133

  • Operating room light
Series 1 300 DT Single CA 1150mm Sgl MH SA Sgl G2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001044 ()
C13S41

  • Operating room light
Series 1 300DT 1150,1000,850 CA, Dual yoke 3P, Dual yoke 9P SL-30M, MH1
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706000986 ()
C13T432351

  • Operating room light
ADMIN SET IV 68" CONVERT PIN W/FLASH BULB 15DPS/MIN 50/CA
ACE SURGICAL SUPPLY CO., INC.
0031400
In Commercial Distribution

  • 10614950009159 ()
  • 00614950009152 ()

  • Length: 68 Inch
0031400

  • Intravenous administration tubing extension set
BUR TREPHINE 23TL 7ID 7.9OD 6.75CL CA 6MM MARKINGS TI 6AL 4V ELI
ACE SURGICAL SUPPLY CO., INC.
04948602
In Commercial Distribution

  • 00614950011872 ()

  • Outer Diameter: 7.9 Millimeter
04948602

  • Titanium dental bur
DRAPE POLYTISSUE W/TIE 40X32 NS 12/PKG DISPOSABLE 5PKG/CA L/F
ACE SURGICAL SUPPLY CO., INC.
0034101
In Commercial Distribution

  • 10614950000095 ()
  • 00614950000098 ()

  • Length: 40 Inch
0034101

  • Patient surgical drape, single-use, non-sterile
DRAPE POLYTISSUE W/TIE 40X52 NS 12/PKG DISPOSABLE 5PKG/CA L/F
ACE SURGICAL SUPPLY CO., INC.
0034100
In Commercial Distribution

  • 10614950000088 ()
  • 00614950000081 ()

  • Length: 52 Inch
0034100

  • Patient surgical drape, single-use, non-sterile
CA 19-9 Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995492
In Commercial Distribution

  • 00630414598192 ()
10995492

  • Cancer antigen 19-9 (CA19-9) IVD, control
CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995488
In Commercial Distribution

  • 00630414598154 ()
10995488

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA 15-3® - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995487
In Commercial Distribution

  • 00630414598147 ()
  • 00630414190655 ()
10995487

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer
FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS701
In Commercial Distribution

  • 05700572030973 ()

  • 20-30 Tests


  • Cancer antigen 125 (CA125) IVD, antibody
ACCUTHRIVE DERMABLADE BIOPSY BLADE SS STERILE USA 400BL/CA (50BL/CT, 8CT/CS)
AccuTec, Inc.
Biopsy Blade
In Commercial Distribution

  • 00843382113834 ()
  • 00843382113827 ()
  • 00843382113841 ()
AVSC-1135-0000

  • Skin biopsy blade
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465910D
In Commercial Distribution

  • 00811403011575 ()


  • Multiple electrolyte IVD, calibrator
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465909D
In Commercial Distribution

  • 00811403011568 ()


  • Multiple electrolyte IVD, calibrator
For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465908D
In Commercial Distribution

  • 00811403011551 ()


  • Multiple electrolyte IVD, calibrator
NOVA CONTROL 3 Na+,K+,Cl-,Ca++,GLU,BUN, TCa,Mg++,Li+,pH
NOVA BIOMEDICAL CORPORATION
3
In Commercial Distribution

  • 00385480186544 ()
  • 00385489186545 ()
18654

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Wipe Down Body Wedge Set, Rounded (1 each-BPW04R/ 1 each-BPW04LR) - 10/ST/CA
PRIMO INC
BPW10R
In Commercial Distribution

  • 10810006683841 ()
  • 00810006683844 ()
BPW10R

  • Freestanding patient positioner, reusable
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm COMFORT | SL | single ended
devemed GmbH
02-2525-40 CT
In Commercial Distribution

  • 04061644039623 ()


  • Periodontal probe, reusable
TITAN-Periodontal Probe # CP15"North Ca" graduated; 1-2...-14-15 mm F-LINE | SL | single ended
devemed GmbH
2525-40 FT
In Commercial Distribution

  • 04061644039616 ()


  • Periodontal probe, reusable
Series 1, 500 DT, Triple CA, 1600mm, 1450mm, 1300mm, (Normal 3P SADual yoke
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009439 ()
C15T76533R

  • Operating room light
Series 1, 500 DT, Dual CA, 1600mm, 1450mm, RAD SHIELD W/910MM, OT50001FA
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009347 ()
C15D764R

  • Operating room light
Set of Optima contre angle and licence code for settings
Bien-Air Dental SA
1700733-001
In Commercial Distribution

  • J00717007330011 ()
1700733-001

  • Surgical power tool system control unit, line-powered
Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700569-001
In Commercial Distribution

  • J00717005690011 ()
1700569-001

  • 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
1700388-001
In Commercial Distribution

  • J00717003880011 ()
1700388-001

  • 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
1601236-001
In Commercial Distribution

  • J00716012360011 ()


  • 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
1601164-001
In Commercial Distribution

  • J00716011640011 ()
1601164-001

  • Dental laboratory drilling system handpiece
CA & 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
1601138-001
In Commercial Distribution

  • J00716011380011 ()
1601138-001

  • Dental power tool system handpiece, remotely-driven
CA & 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
1601137-001
In Commercial Distribution

  • J00716011370011 ()
1601137-001

  • Dental power tool system handpiece, remotely-driven
CA & 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
1601136-001
In Commercial Distribution

  • J00716011360011 ()
1601136-001

  • 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
1601058-001
In Commercial Distribution

  • J00716010580011 ()
1601058-001

  • Pneumatic dental handpiece coupler
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
1601057-001
In Commercial Distribution

  • J00716010570011 ()
1601057-001

  • 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
1601055-001
In Commercial Distribution

  • J00716010550011 ()
1601055-001

  • 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
1601011-001
In Commercial Distribution

  • J00716010110011 ()
1601011-001

  • 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
1600941-001
In Commercial Distribution

  • J00716009410011 ()
1600941-001

  • 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
1600939-001
In Commercial Distribution

  • J00716009390011 ()
1600939-001

  • 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
1600874-001
In Commercial Distribution

  • J00716008740011 ()
1600874-001

  • Dental laboratory drilling system handpiece
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