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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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E-CUBE - 08809260470484

Implant Motor
Saeshin Precision Co., Ltd.
CUBE-EP
In Commercial Distribution

  • 08809260470484 ()


  • Dental power tool system, line-powered

E-CUBE - 08809260470477

Control Box
Saeshin Precision Co., Ltd.
E-CUBE(C/B)
In Commercial Distribution

  • 08809260470477 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470460

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-61I
In Commercial Distribution

  • 08809260470460 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470453

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-45I
In Commercial Distribution

  • 08809260470453 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470446

No Description
Saeshin Precision Co., Ltd.
ACL(B)-43I
In Commercial Distribution

  • 08809260470446 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470439

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-42I
In Commercial Distribution

  • 08809260470439 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470422

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-41I
In Commercial Distribution

  • 08809260470422 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470415

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL-45I
In Commercial Distribution

  • 08809260470415 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470408

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL-43I
In Commercial Distribution

  • 08809260470408 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470392

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL-42I
In Commercial Distribution

  • 08809260470392 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470385

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL-41I
In Commercial Distribution

  • 08809260470385 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470378

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-03F
In Commercial Distribution

  • 08809260470378 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470361

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-04C
In Commercial Distribution

  • 08809260470361 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470354

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-03C
In Commercial Distribution

  • 08809260470354 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470347

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-01C
In Commercial Distribution

  • 08809260470347 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470330

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

  • 08809260470330 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470323

No Description
Saeshin Precision Co., Ltd.
ACL-01C
In Commercial Distribution

  • 08809260470323 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470316

Angle Handpiece
Saeshin Precision Co., Ltd.
AT-II
In Commercial Distribution

  • 08809260470316 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470309

Implant Motor
Saeshin Precision Co., Ltd.
Forte 100αEI
In Commercial Distribution

  • 08809260470309 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470286

Control Box
Saeshin Precision Co., Ltd.
X-CUBE
In Commercial Distribution

  • 08809260470286 ()


  • Dental power tool system, line-powered

TRAUS ENDO - 08809260470262

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-42EP
In Commercial Distribution

  • 08809260470262 ()


  • Dental power tool system, line-powered

TRAUS ENDO - 08809260470255

Angle Handpiece
Saeshin Precision Co., Ltd.
ACL(B)-41EP
In Commercial Distribution

  • 08809260470255 ()


  • Dental power tool system, line-powered

TRAUS ENDO - 08809260470248

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

  • 08809260470248 ()


  • Dental power tool system, line-powered

TRAUS ENDO - 08809260470231

Control Box
Saeshin Precision Co., Ltd.
TRAUS MCE10XX
In Commercial Distribution

  • 08809260470231 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260470200

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

TRAUS SIP10 - 08809260470163

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

TRAUS SUS10 - 08809260470125

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

  • 08809260470125 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470118

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

  • 08809260470118 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470101

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

  • 08809260470101 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470095

32:1 , non-optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470095 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470088

32:1 , optic
Saeshin Precision Co., Ltd.
TRAUS SUS10
In Commercial Distribution

  • 08809260470088 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470071

92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB27LX
In Commercial Distribution

  • 08809260470071 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470064

92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB27XX
In Commercial Distribution

  • 08809260470064 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470057

92.7(L) x 20.0(D)
Saeshin Precision Co., Ltd.
TRAUS CRB26LX
In Commercial Distribution

  • 08809260470057 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470040

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

  • 08809260470040 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470033

127.6(L) x 25.7(D)
Saeshin Precision Co., Ltd.
TRAUS MBP10SX
In Commercial Distribution

  • 08809260470033 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470026

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

  • 08809260470026 ()


  • Dental power tool system, line-powered

TRAUS SUS10 - 08809260470019

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

TRAUS SUS10 - 08809260470002

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

Bioseal Inc. - 00630094183107

Catheter 5Fr
BIOSEAL
18310/50
In Commercial Distribution

  • 10630094183104 ()
  • 00630094183107 ()


  • Nephrostomy catheter

Bioseal Inc. - 00630094179209

Catheter Tips 4 Sizes
BIOSEAL
17920/10
In Commercial Distribution

  • 10630094179206 ()
  • 00630094179209 ()


  • Nephrostomy catheter

Bioseal Inc. - 00630094179124

Medena Continent Catheter
BIOSEAL
17912/25
In Commercial Distribution

  • 10630094179121 ()
  • 00630094179124 ()


  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021469

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 14F
URESIL, LLC
NCL2-1450HB
In Commercial Distribution

  • 10817640021466 ()
  • 00817640021469 ()
  • 20817640021463 ()
  • H862NCL21450HB0 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
NCL2-1450HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021452

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 14F
URESIL, LLC
NCL2-1435HB
In Commercial Distribution

  • 10817640021459 ()
  • 00817640021452 ()
  • 20817640021456 ()
  • H862NCL21435HB0 ()

  • Catheter Gauge: 14 French
  • Length: 28 Centimeter
NCL2-1435HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021445

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 12F
URESIL, LLC
NCL2-1250HB
In Commercial Distribution

  • 10817640021442 ()
  • 00817640021445 ()
  • 20817640021449 ()
  • H862NCL21250HB0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
NCL2-1250HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021438

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 12F
URESIL, LLC
NCL2-1235HB
In Commercial Distribution

  • 10817640021435 ()
  • 00817640021438 ()
  • 20817640021432 ()
  • H862NCL21235HB0 ()

  • Catheter Gauge: 12 French
  • Length: 27 Centimeter
NCL2-1235HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021421

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 10F
URESIL, LLC
NCL2-1050HB
In Commercial Distribution

  • 10817640021428 ()
  • 00817640021421 ()
  • 20817640021425 ()
  • H862NCL21050HB0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
NCL2-1050HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021407

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 10F
URESIL, LLC
NCL2-1035HB
In Commercial Distribution

  • 10817640021404 ()
  • 00817640021407 ()
  • 20817640021401 ()
  • H862NCL21035HB0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2-1035HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021391

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 8F
URESIL, LLC
NCL2-0850HB
In Commercial Distribution

  • 10817640021398 ()
  • 00817640021391 ()
  • 20817640021395 ()
  • H862NCL20850HB0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
NCL2-0850HB

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - 00817640021377

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 8F
URESIL, LLC
NCL2-0835HB
Not in Commercial Distribution

  • 10817640021374 ()
  • 00817640021377 ()
  • 20817640021371 ()
  • H862NCL20835HB0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB

  • Nephrostomy catheter
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