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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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ZOLL-DENTAL - 00840105213031

Gracey-Long/Rigid 9/10
Zoll-Dental
S-GRALR9/10
In Commercial Distribution

  • 00840105213031 ()


  • Manual dental scaler, reusable

IMPIX ALIF - 03613720193395

IMPIX-ALIF 12mm at 9°
MEDICREA INTERNATIONAL
B15111209
Not in Commercial Distribution

  • 03613720193395 ()
B15111209

  • Polymeric spinal interbody fusion cage

IMPIX-ALIF & ALIF D - 03613720218302

ALIF TRIAL 16mm - 9°
MEDICREA INTERNATIONAL
A15211609
Not in Commercial Distribution

  • 03613720218302 ()


  • Spinal implant trial

IMPIX-ALIF & ALIF D - 03613720218272

ALIF TRIAL 14mm - 9°
MEDICREA INTERNATIONAL
A15211409
Not in Commercial Distribution

  • 03613720218272 ()


  • Spinal implant trial

IMPIX-ALIF & ALIF D - 03613720218241

ALIF TRIAL 12mm - 9°
MEDICREA INTERNATIONAL
A15211209
Not in Commercial Distribution

  • 03613720218241 ()


  • Spinal implant trial

IMPIX-ALIF & ALIF D - 03613720218210

ALIF TRIAL 10mm - 9°
MEDICREA INTERNATIONAL
A15211009
Not in Commercial Distribution

  • 03613720218210 ()


  • Spinal implant trial

Millennium - 00190776133108

BIPOL KEYFIN 1.2T 9"
Avalign Technologies, Inc.
100-S03247FG
In Commercial Distribution

  • 00190776133108 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Millennium - 00190776131395

BIPOL KEYFIN 1T 9"
Avalign Technologies, Inc.
100-S03245FG
In Commercial Distribution

  • 00190776131395 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Trinity Sterile, Inc. - 10841767100131

MAYO SCISSOR STR 9"
Trinity Sterile, Inc.
6096
In Commercial Distribution

  • 00841767100134 ()
  • 10841767100131 ()


  • General-purpose surgical scissors, single-use

Millennium - 00190776401771

Thomas-Gaylor Biopsy Forceps, 9"
Avalign Technologies, Inc.
1-301410
In Commercial Distribution

  • 00190776401771 ()


  • Open-surgery biopsy forceps, reusable

Millennium - 00190776394707

Bone Hook, semi-sharp, 9"
Avalign Technologies, Inc.
1-HOOK9C
In Commercial Distribution

  • 00190776394707 ()


  • Bone hook

Millennium - 00190776385347

Rochester-Carmalt Forceps, 9" Curved
Avalign Technologies, Inc.
1-MG197R
In Commercial Distribution

  • 00190776385347 ()


  • Towel clamp, reusable

MILLENNIUM - 00190776294038

Lucae Mallet 9 oz
Avalign Technologies, Inc.
0-46660
In Commercial Distribution

  • 00190776294038 ()


  • Surgical mallet

MILLENNIUM - 00190776292690

Molt Periosteal Elevator, #9
Avalign Technologies, Inc.
17-090394
In Commercial Distribution

  • 00190776292690 ()


  • Periosteal elevator, reusable

BONE GRAFT DELIVERY - 00840606125932

GUN PUSHER - LARGE 9"
SPINAL ELEMENTS, INC.
11377-004
In Commercial Distribution

  • 00840606125932 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

BONE GRAFT DELIVERY - 00840606125864

DELIVERY TUBE - LARGE 9"
SPINAL ELEMENTS, INC.
11376-004
In Commercial Distribution

  • 00840606125864 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Millennium - 00190776155094

BIPOLAR KEYFIN .7T 9"
Avalign Technologies, Inc.
100-S03243FG
In Commercial Distribution

  • 00190776155094 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Trinity Sterile, Inc. - 10841767107154

KELLY HEMOSTAT CRV 9"
Trinity Sterile, Inc.
7038
In Commercial Distribution

  • 00841767107157 ()
  • 10841767107154 ()


  • Dressing/utility forceps, scissors-like, single-use

Trinity Sterile, Inc. - 10841767107062

METZENBAUM SCISSOR STR 9"
Trinity Sterile, Inc.
6090
In Commercial Distribution

  • 00841767107065 ()
  • 10841767107062 ()


  • General-purpose surgical scissors, single-use

Trinity Sterile, Inc. - 10841767107079

METZENBAUM SCISSOR CRV 9"
Trinity Sterile, Inc.
6091
In Commercial Distribution

  • 00841767107072 ()
  • 10841767107079 ()


  • General-purpose surgical scissors, single-use

PaediGAV® - 04041906115708

PAEDIGAV SYSTEM 9/29
Christoph Miethke GmbH & Co. KG
FV281T
Not in Commercial Distribution

  • 04041906115708 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 29.000 CWS
FV281T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906115609

PAEDIGAV SYSTEM 9/24
Christoph Miethke GmbH & Co. KG
FV280T
Not in Commercial Distribution

  • 04041906115609 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 24.000 CWS
FV280T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906115500

PAEDIGAV SYSTEM 9/19
Christoph Miethke GmbH & Co. KG
FV279T
Not in Commercial Distribution

  • 04041906115500 ()

  • Pressure rating vert. (cmH2O) : 19.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV279T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906114565

PAEDIGAV VALVE 9/29
Christoph Miethke GmbH & Co. KG
FV295T
Not in Commercial Distribution

  • 04041906114565 ()

  • Pressure rating vert. (cmH2O) : 29.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV295T

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906114558

PAEDIGAV VALVE 9/24
Christoph Miethke GmbH & Co. KG
FV294T
Not in Commercial Distribution

  • 04041906114558 ()

  • Pressure rating vert. (cmH2O) : 24.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV294T

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906114541

PAEDIGAV VALVE 9/19
Christoph Miethke GmbH & Co. KG
FV293T
Not in Commercial Distribution

  • 04041906114541 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 19.000 CWS
FV293T

  • Cerebrospinal fluid shunt valve

Octane T - 00840996154260

OCTANE T,TRIAL,9
Choice Spine, LP
600-9209
In Commercial Distribution

  • 00840996154260 ()


  • Polymeric spinal interbody fusion cage

Octane P - 00840996154468

OCTANE P,TRIAL,9
Choice Spine, LP
601-9209
In Commercial Distribution

  • 00840996154468 ()


  • Polymeric spinal interbody fusion cage

Octane T - 00840996153805

OCTANE T,TRIAL,9
Choice Spine, LP
05-049-01-0009
In Commercial Distribution

  • 00840996153805 ()


  • Polymeric spinal interbody fusion cage

NORDENT MANUFACTURING INC - 00840018605220

SINGLE END EXPLORER 9
NORDENT MANUFACTURING INC
EXS9
In Commercial Distribution

  • 00840018605220 ()


  • Dental surgical probe, reusable
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