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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1:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-01C
Saeshin Precision Co., Ltd.
X-CUBE #4
In Commercial Distribution

  • 08809260470811 ()


  • Dental power tool system, line-powered
'1:1, Contra Angle(Lever Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-02C
Saeshin Precision Co., Ltd.
X-CUBE #3
In Commercial Distribution

  • 08809260470804 ()


  • Dental power tool system, line-powered
'1:1, Contra Angle(Lever Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C
Saeshin Precision Co., Ltd.
X-CUBE #2
In Commercial Distribution

  • 08809260470798 ()


  • Dental power tool system, line-powered
Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-41EP
In Commercial Distribution

  • 08809260470255 ()


  • Dental power tool system, line-powered
Control Box
Saeshin Precision Co., Ltd.
TRAUS MCE10XX
In Commercial Distribution

  • 08809260470231 ()


  • Dental power tool system, line-powered
Control Box 272.0(W) x 203.0(D) x 67.4(H)
Saeshin Precision Co., Ltd.
TRAUS XIP10
In Commercial Distribution

  • 08809260470163 ()


  • Dental power tool system, line-powered
20:1, Non-optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470118 ()


  • Dental power tool system, line-powered
32:1 , non-optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470095 ()


  • Dental power tool system, line-powered
32:1 , optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470088 ()


  • Dental power tool system, line-powered
92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB27XX
In Commercial Distribution

  • 08809260470064 ()


  • Dental power tool system, line-powered
92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB26LX
In Commercial Distribution

  • 08809260470057 ()


  • Dental power tool system, line-powered
127.6(L) x 25.7(D)
Saeshin Precision Co., Ltd.
TRAUS MBP10SX
In Commercial Distribution

  • 08809260470033 ()


  • Dental power tool system, line-powered
272.0(W) x 203.0(D) x 67.4(H)
Saeshin Precision Co., Ltd.
TRAUS FUS10
In Commercial Distribution

  • 08809260470019 ()


  • Dental power tool system, line-powered
Catheter 5Fr
BIOSEAL
18310/50
In Commercial Distribution

  • 10630094183104 ()
  • 00630094183107 ()


  • Nephrostomy catheter
Catheter Tips 3 Sizes
BIOSEAL
17922/25
In Commercial Distribution

  • 10630094179220 ()
  • 00630094179223 ()


  • Nephrostomy catheter
Catheter Tips 4 Sizes
BIOSEAL
17920/10
In Commercial Distribution

  • 10630094179206 ()
  • 00630094179209 ()


  • Nephrostomy catheter
Medena Continent Catheter
BIOSEAL
17912/25
In Commercial Distribution

  • 10630094179121 ()
  • 00630094179124 ()


  • Nephrostomy catheter
No Description
NAKANISHI INC.
EL400 CD
Not in Commercial Distribution

  • 04560224986819 ()


  • Dental power tool system, line-powered
No Description
NAKANISHI INC.
Ti-Max TIM40J
Not in Commercial Distribution

  • 04560224972287 ()


  • Dental power tool system, line-powered
Uro-EZDilate KIT 18Fr(6mm) X 10cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0610K
In Commercial Distribution

  • 00821925033153 ()


  • Nephrostomy catheter
Uro-EXDilate 18Fr (6mm) X 10cm URETERAL BALLOON DILATION CATHERTER
Gyrus ACMI, LLC
BURS0610
In Commercial Distribution

  • 00821925033146 ()


  • Nephrostomy catheter
Uro-EZDilate 18Fr (6mm) X 4cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0604
In Commercial Distribution

  • 00821925033122 ()


  • Nephrostomy catheter
Uro-EZDilate KIT 15Fr (5mm) X 10cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BURS0510K
In Commercial Distribution

  • 00821925033115 ()


  • Nephrostomy catheter
Uro-EZDilate 15Fr (5mm) x 10cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0510
In Commercial Distribution

  • 00821925033108 ()


  • Nephrostomy catheter
Uro-EZDilate KIT 15Fr (5mm) x 4cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BURS0504K
In Commercial Distribution

  • 00821925033092 ()


  • Nephrostomy catheter
Uro-EZDilate 15Fr (5mm) x 4cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0504
In Commercial Distribution

  • 00821925033085 ()


  • Nephrostomy catheter
Uro-EZDilatE KIT 12Fr (4mm) x 10cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BURS0410K
In Commercial Distribution

  • 00821925033078 ()


  • Nephrostomy catheter
Uro-EZDilate 12Fr (4mm) X 10 cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0410
In Commercial Distribution

  • 00821925033061 ()


  • Nephrostomy catheter
Uro-EZDilate KIT 12Fr (4mm) x 4cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BURS0404K
In Commercial Distribution

  • 00821925033054 ()


  • Nephrostomy catheter
Uro-EZDilate 12FR (4mm) x 4cm URETERAL BALLOON DILATION CATHETER
Gyrus ACMI, LLC
BURS0404
In Commercial Distribution

  • 00821925033047 ()


  • Nephrostomy catheter
Nephro-EZDilate KIT 30Fr (10mm) X 15cm NEPHROSTOMY BALLOON CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BPCN1015K
In Commercial Distribution

  • 00821925033030 ()


  • Nephrostomy catheter
Nephro-EZDilate 30FR (10mm) X 15cm NEPHROSTOMY BALLOON CATHETER
Gyrus ACMI, LLC
BPCN1015
In Commercial Distribution

  • 00821925033023 ()


  • Nephrostomy catheter
Nephro-EZDilate KIT 24FR (8mm) x 15cm NEPHROSTOMY BALLOON CATHETER AND INFLATION DEVICE
Gyrus ACMI, LLC
BPCN0815K
In Commercial Distribution

  • 00821925033016 ()


  • Nephrostomy catheter
Nephro-EZDilate 24FR (8mm) x 15cm NEPHROSTOMY BALLOON CATHETER
Gyrus ACMI, LLC
BPCN0815
In Commercial Distribution

  • 00821925033009 ()


  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 12F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 12F, 30cm
In Commercial Distribution

  • 10812261019229 ()
  • 00812261019222 ()
PCN-P12

  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 10F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 10F, 30cm
In Commercial Distribution

  • 10812261012312 ()
  • 00812261012315 ()
PCN-P10

  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 9F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 9F, 30cm
In Commercial Distribution

  • 10812261012305 ()
  • 00812261012308 ()
PCN-P9

  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm
In Commercial Distribution

  • 10812261012299 ()
  • 00812261012292 ()
PCN-P8

  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 7F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 7F, 30cm
In Commercial Distribution

  • 10812261012282 ()
  • 00812261012285 ()
PCN-P7

  • Nephrostomy catheter
allDrain Percutaneous Nephrostomy Catheter Pigtail- 14F, 30cm
ALLWIN MEDICAL DEVICES, INC.
allDrain Percutaneous Nephrostomy Catheter Pigtail- 14F, 30cm
In Commercial Distribution

  • 10812261011803 ()
  • 00812261011806 ()
PCN-P14

  • Nephrostomy catheter
Motor for New Drill Unit
BICON, LLC
260-028-425
In Commercial Distribution

  • 00813110023452 ()
260-028-425

  • Dental power tool system, line-powered
Electric Drill Unit
BICON, LLC
260-028-150
In Commercial Distribution

  • 00813110023414 ()
260-028-150

  • Dental power tool system, line-powered
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 14F
URESIL, LLC
NCL2T-1450HB
In Commercial Distribution

  • 10817640021091 ()
  • 00817640021094 ()
  • 20817640021098 ()
  • H862NCL2T1450HB0 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
NCL2T-1450HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 12F
URESIL, LLC
NCL2T-1250HB
In Commercial Distribution

  • 10817640021077 ()
  • 00817640021070 ()
  • 20817640021074 ()
  • H862NCL2T1250HB0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
NCL2T-1250HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 10F
URESIL, LLC
NCL2T-1050HB
In Commercial Distribution

  • 10817640021053 ()
  • 00817640021056 ()
  • 20817640021050 ()
  • H862NCL2T1050HB0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
NCL2T-1050HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 10F
URESIL, LLC
NCL2T-1035H
In Commercial Distribution

  • 10817640021046 ()
  • 00817640021049 ()
  • 20817640021043 ()
  • H862NCL2T1035H0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2T-1035H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
URESIL, LLC
NSL2-1028H
In Commercial Distribution

  • 10817640020452 ()
  • 00817640020455 ()
  • 20817640020459 ()
  • H862NSL21028H0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NSL2-1028H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
URESIL, LLC
NSL2-1026H
In Commercial Distribution

  • 10817640020445 ()
  • 00817640020448 ()
  • 20817640020442 ()
  • H862NSL21026H0 ()

  • Catheter Gauge: 10 French
  • Length: 26 Centimeter
NSL2-1026H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
URESIL, LLC
NSL2-1024H
In Commercial Distribution

  • 10817640020438 ()
  • 00817640020431 ()
  • 20817640020435 ()
  • H862NSL21024H0 ()

  • Catheter Gauge: 10 French
  • Length: 24 Centimeter
NSL2-1024H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
URESIL, LLC
NSL2-1022H
In Commercial Distribution

  • 10817640020421 ()
  • 00817640020424 ()
  • 20817640020428 ()
  • H862NSL21022H0 ()

  • Catheter Gauge: 10 French
  • Length: 22 Centimeter
NSL2-1022H

  • Nephrostomy catheter
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