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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Angle Handpiece
Saeshin Precision Co., Ltd.
ACL-02C
In Commercial Distribution

  • 08809260470330 ()


  • Dental power tool system, line-powered
No Description
Saeshin Precision Co., Ltd.
ACL-01C
In Commercial Distribution

  • 08809260470323 ()


  • Dental power tool system, line-powered
Angle Handpiece
Saeshin Precision Co., Ltd.
AT-II
In Commercial Distribution

  • 08809260470316 ()


  • Dental power tool system, line-powered
Implant Motor
Saeshin Precision Co., Ltd.
Forte 100αEI
In Commercial Distribution

  • 08809260470309 ()


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

  • 08809260470286 ()


  • Dental power tool system, line-powered
Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-42EP
In Commercial Distribution

  • 08809260470262 ()


  • 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
Charger
Saeshin Precision Co., Ltd.
TRAUS XEW10
In Commercial Distribution

  • 08809260470248 ()


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

  • 08809260470231 ()


  • Dental power tool system, line-powered
Angle Handpiece 92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB26XX
In Commercial Distribution

  • 08809260470200 ()


  • 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
145.3(L) x 23.8(D)
Saeshin Precision Co., Ltd.
TRAUS PEZ10XX
In Commercial Distribution

  • 08809260470125 ()


  • 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
20.:1 , optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470101 ()


  • 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 CRB27LX
In Commercial Distribution

  • 08809260470071 ()


  • 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
92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB26XX
In Commercial Distribution

  • 08809260470040 ()


  • 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
127.6(L) x 25.7(D)
Saeshin Precision Co., Ltd.
TRAUS MBP10SL
In Commercial Distribution

  • 08809260470026 ()


  • 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
348.0(W) x 276.0(D) x 143.0(H)
Saeshin Precision Co., Ltd.
TRAUS XUS10
In Commercial Distribution

  • 08809260470002 ()


  • Dental power tool system, line-powered
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
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
Nuance Nephrostomy Drainage Catheter 12F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10529
In Commercial Distribution

  • H965105291 ()
  • H965105290 ()
  • 15051684022743 ()

  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 12 French
  • Length: 35 Centimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 14F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10524
In Commercial Distribution

  • H965105241 ()
  • H965105240 ()
  • 15051684022699 ()

  • Catheter Gauge: 14 French
  • Length: 35 Centimeter
  • Outer Diameter: 4.7 Millimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 10F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10518
In Commercial Distribution

  • H965105181 ()
  • H965105180 ()
  • 15051684022651 ()

  • Length: 25 Centimeter
  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 8F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10516
In Commercial Distribution

  • H965105161 ()
  • H965105160 ()
  • 15051684022644 ()

  • Catheter Gauge: 8 French
  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 6F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10514
In Commercial Distribution

  • H965105141 ()
  • H965105140 ()
  • 15051684022637 ()

  • Catheter Gauge: 6 French
  • Length: 25 Centimeter
  • Outer Diameter: 2.1 Millimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 14F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10428
In Commercial Distribution

  • H965104281 ()
  • H965104280 ()
  • 15051684022583 ()

  • Outer Diameter: 4.7 Millimeter
  • Catheter Gauge: 14 French
  • Length: 25 Centimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 12F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10424
In Commercial Distribution

  • H965104241 ()
  • H965104240 ()
  • 15051684022569 ()

  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 12 French
  • Length: 25 Centimeter


  • Nephrostomy catheter
10F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10415
Not in Commercial Distribution

  • H965104151 ()
  • H965104150 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 25 Centimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 10F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10412
In Commercial Distribution

  • H965104121 ()
  • H965104120 ()
  • 15051684022545 ()

  • Length: 25 Centimeter
  • Catheter Gauge: 10 French
  • Outer Diameter: 3.4 Millimeter


  • Nephrostomy catheter
Nuance Nephrostomy Drainage Catheter 8F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10407
In Commercial Distribution

  • H965104071 ()
  • H965104070 ()
  • 15051684022521 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Nephrostomy catheter
8F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10404
Not in Commercial Distribution

  • H965104041 ()
  • H965104040 ()

  • Catheter Gauge: 8 French
  • Length: 25 Centimeter
  • Outer Diameter: 2.7 Millimeter


  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48183
In Commercial Distribution

  • 00827002481831 ()
ULT8.5-8.5-28-NUCL-B-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48182
In Commercial Distribution

  • 00827002481824 ()
ULT8.5-8.5-28-NUCL-A-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48180
In Commercial Distribution

  • 00827002481800 ()
ULT8.5-8.5-26-NUCL-B-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48179
In Commercial Distribution

  • 00827002481794 ()
ULT8.5-8.5-26-NUCL-A-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48176
In Commercial Distribution

  • 00827002481763 ()
ULT8.5-8.5-24-NUCL-B-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48175
In Commercial Distribution

  • 00827002481756 ()
ULT8.5-8.5-24-NUCL-A-RH

  • Nephrostomy catheter
Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48173
In Commercial Distribution

  • 00827002481732 ()
ULT8.5-8.5-22-NUCL-B-RH

  • Nephrostomy catheter
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