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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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Cope - 00827002481619

Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48161
In Commercial Distribution

  • 00827002481619 ()
ULT10.2-10.2-22-NUCL-A-RH

  • Nephrostomy catheter

Cope - 00827002481602

Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48160
In Commercial Distribution

  • 00827002481602 ()
ULT10.2-10.2-20-NUCL-B-RH

  • Nephrostomy catheter

Cope - 00827002481596

Cope Nephroureterostomy Stent Ultrathane
COOK INCORPORATED
G48159
In Commercial Distribution

  • 00827002481596 ()
ULT10.2-10.2-20-NUCL-A-RH

  • Nephrostomy catheter

Cook - 00827002478060

Circle Nephrostomy Catheter Set
COOK INCORPORATED
G47806
In Commercial Distribution

  • 00827002478060 ()
CNCS-166000

  • Nephrostomy catheter

Cook - 00827002478053

Circle Nephrostomy Catheter Set
COOK INCORPORATED
G47805
In Commercial Distribution

  • 00827002478053 ()
CNCS-146000

  • Nephrostomy catheter

Ultraxx - 00827002476585

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G47658
In Commercial Distribution

  • 00827002476585 ()
UNBS-10-15-CS-01

  • Nephrostomy catheter

Ultraxx - 00827002476493

Ultraxx Nephrostomy Balloon Set
COOK INCORPORATED
G47649
In Commercial Distribution

  • 00827002476493 ()
UNBS-10-15-01

  • Nephrostomy catheter

Ultraxx - 00827002476479

Ultraxx Nephrostomy Balloon Set
COOK INCORPORATED
G47647
In Commercial Distribution

  • 00827002476479 ()
UNBS-8-15-01

  • Nephrostomy catheter

Ultraxx - 00827002476462

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G47646
In Commercial Distribution

  • 00827002476462 ()
UNBS-6-15-CS-01

  • Nephrostomy catheter

Ultraxx - 00827002460386

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46038
In Commercial Distribution

  • 00827002460386 ()
UNBS-8-15-CS

  • Nephrostomy catheter

Ultraxx - 00827002460379

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46037
In Commercial Distribution

  • 00827002460379 ()
UNBS-6-15-CS

  • Nephrostomy catheter

Ultraxx - 00827002460362

Ultraxx Nephrostomy Balloon Set
COOK INCORPORATED
G46036
In Commercial Distribution

  • 00827002460362 ()
UNBS-6-15

  • Nephrostomy catheter

Ultraxx - 00827002460355

Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46035
In Commercial Distribution

  • 00827002460355 ()
UNB-8-15-CS

  • Nephrostomy catheter

Ultraxx - 00827002460348

Ultraxx Nephrostomy Balloon
COOK INCORPORATED
G46034
In Commercial Distribution

  • 00827002460348 ()
UNB-8-15

  • Nephrostomy catheter

Ultraxx - 00827002460232

Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46023
In Commercial Distribution

  • 00827002460232 ()
UNB-6-15-CS

  • Nephrostomy catheter

Exodus - H965105290

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

Exodus - H965105240

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

Exodus - H965105180

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

Exodus - H965105160

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

Exodus - H965105140

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

Exodus - H965104280

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

Exodus - H965104240

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

Exodus - H965104150

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

Exodus - H965104120

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

Exodus - H965104070

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

Exodus - H965104040

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

TRAUS SIP20 - 08809260472181

No Description
Saeshin Precision Co., Ltd.
TRAUS BIP20
In Commercial Distribution

  • 08809260472181 ()


  • Dental power tool system, line-powered

TRAUS SUS20 - 08809260472174

No Description
Saeshin Precision Co., Ltd.
TRAUS PEZ10LN
In Commercial Distribution

  • 08809260472174 ()


  • Dental power tool system, line-powered

TRAUS SUS20 - 08809260472167

No Description
Saeshin Precision Co., Ltd.
TRAUS BUS20
In Commercial Distribution

  • 08809260472167 ()


  • Dental power tool system, line-powered

TRAUS SUS20 - 08809260472150

non-optic / BUS20+FUS10+PEZ10XX
Saeshin Precision Co., Ltd.
TRAUS SUS20#2
In Commercial Distribution

  • 08809260472150 ()


  • Dental power tool system, line-powered

TRAUS SUS20 - 08809260472143

optic / BUS20+FUS10+PEZ10LN
Saeshin Precision Co., Ltd.
TRAUS SUS20#1
In Commercial Distribution

  • 08809260472143 ()


  • Dental power tool system, line-powered

TRAUS SIP20 - 08809260471689

BIP20+MBP10SL+FUS10+CRB46LN
Saeshin Precision Co., Ltd.
TRAUS SIP20#1
In Commercial Distribution

  • 08809260471689 ()


  • Dental power tool system, line-powered

TRAUS Dental Handpiece - 08809260471566

20:1, Non-Optic
Saeshin Precision Co., Ltd.
TRAUS CRB46NN
In Commercial Distribution

  • 08809260471566 ()


  • Dental power tool system, line-powered

TRAUS Dental Handpiece - 08809260471559

'20:1, Optic
Saeshin Precision Co., Ltd.
TRAUS CRB46LN
In Commercial Distribution

  • 08809260471559 ()


  • Dental power tool system, line-powered

TRAUS - 08809260471214

Angle Handpiece Non-Optic 1:1
Saeshin Precision Co., Ltd.
AT-II
In Commercial Distribution

  • 08809260471214 ()


  • Dental power tool system, line-powered

TRAUS - 08809260471207

Angle Handpiece 1:1
Saeshin Precision Co., Ltd.
ACL(B)-03F
In Commercial Distribution

  • 08809260471207 ()


  • Dental power tool system, line-powered

TRAUS - 08809260471191

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

  • 08809260471191 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471054

20:1 , non-optic X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+TRAUS CRB27XX
Saeshin Precision Co., Ltd.
X-CUBE #18
In Commercial Distribution

  • 08809260471054 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471047

32:1 , non-optic X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+TRAUS CRB26XX
Saeshin Precision Co., Ltd.
X-CUBE #17
In Commercial Distribution

  • 08809260471047 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471030

'20:1, Contra Angle(Button Type #2) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEIP+ACL(B)-61I
Saeshin Precision Co., Ltd.
X-CUBE #16
In Commercial Distribution

  • 08809260471030 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471023

32:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-45I
Saeshin Precision Co., Ltd.
X-CUBE #15
In Commercial Distribution

  • 08809260471023 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471016

64:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-43I
Saeshin Precision Co., Ltd.
X-CUBE #14
In Commercial Distribution

  • 08809260471016 ()


  • Dental power tool system, line-powered

X-CUBE - 08809260471009

16:1, Contra Angle(Button Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL(B)-42I
Saeshin Precision Co., Ltd.
X-CUBE #13
In Commercial Distribution

  • 08809260471009 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470989

'Oscillating BSG10+TRAUS FUS10+MBP10SX+CRT14XX+CST10XX+TST10XX
Saeshin Precision Co., Ltd.
TRAUS SSG10 #6
In Commercial Distribution

  • 08809260470989 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470972

'reciprocating BSG10+TRAUS FUS10+MBP10SL+CRB26LX+MBP10SX+CRT14XX+CST10XX+TST10XX+TRT12NRC+TRT12NSG+TRT12NOS
Saeshin Precision Co., Ltd.
TRAUS SSG10 #5
In Commercial Distribution

  • 08809260470972 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470965

32:1 , non-optic BSG10+TRAUS FUS10+MBP10SX+CRB27XX
Saeshin Precision Co., Ltd.
TRAUS SSG10 #4
In Commercial Distribution

  • 08809260470965 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470958

32:1 , optic BSG10+TRAUS FUS10+MBP10SL+CRB27LX
Saeshin Precision Co., Ltd.
TRAUS SSG10 #3
In Commercial Distribution

  • 08809260470958 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470941

20:1 , non-optic BSG10+TRAUS FUS10+MBP10SX+CRB26XX
Saeshin Precision Co., Ltd.
TRAUS SSG10 #2
In Commercial Distribution

  • 08809260470941 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470934

20:1 , optic BSG10+TRAUS FUS10+MBP10SL+CRB26LX
Saeshin Precision Co., Ltd.
TRAUS SSG10 #1
In Commercial Distribution

  • 08809260470934 ()


  • Dental power tool system, line-powered

TRAUS SSG10 - 08809260470927

'Sagittal
Saeshin Precision Co., Ltd.
TRAUS SSG10 #7
In Commercial Distribution

  • 08809260470927 ()


  • Dental power tool system, line-powered
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