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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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ULTRAPOWER - 10845854000830

ULTRAPOWER BUR, ROUND (LIME), 9 MM
Conmed Corporation
00702133200
In Commercial Distribution

  • 10845854000830 ()

  • Outer Diameter: 9 Millimeter
7021-332

  • Orthopaedic bur, single-use

KWIK-STIK™ - 10845357041576

KWIK-STIK™ S. aureus BD 9
MICROBIOLOGICS INC.
01126U
In Commercial Distribution

  • 10845357041576 ()
01126U

  • Multiple bacteria species culture isolate identification control IVD, kit

OVERWATCH - 00840606159586

K-WIRE CADDY 9" BLUNT THREADED NI
SPINAL ELEMENTS, INC.
108-327-023
In Commercial Distribution

  • 00840606159586 ()


  • Device sterilization/disinfection container, reusable

OVERWATCH - 00840606159432

K-WIRE CADDY 9" TROCAR THREADED SS
SPINAL ELEMENTS, INC.
108-327-004
In Commercial Distribution

  • 00840606159432 ()


  • Device sterilization/disinfection container, reusable

OVERWATCH - 00840606159425

K-WIRE CADDY 9" BLUNT THREADED SS
SPINAL ELEMENTS, INC.
108-327-003
In Commercial Distribution

  • 00840606159425 ()


  • Device sterilization/disinfection container, reusable

Millennium - 00190776297008

Knot Pusher, Stainless Steel, Style 9
Avalign Technologies, Inc.
72-522306109
In Commercial Distribution

  • 00190776297008 ()


  • Suture knot pusher, reusable

AESCULAP - 04038653180653

Needleholder, 9", (225 mm), non-sterile, reusable
Aesculap AG
OP402R
In Commercial Distribution

  • 04038653180653 ()
OP402R

  • Suturing needle holder, reusable

Millennium - 00190776304546

Inge Retractor 9 12" with teeth
Avalign Technologies, Inc.
1-290150
In Commercial Distribution

  • 00190776304546 ()


  • Self-retaining surgical retractor, reusable

Millennium - 00190776301910

TC CRILE-WOOD NEEDLE HOLDER 9" SERRATED
Avalign Technologies, Inc.
1-4101
In Commercial Distribution

  • 00190776301910 ()


  • Suturing needle holder, reusable

Millennium - 00190776299446

ZEP HYST FCPS STR 9 12"
Avalign Technologies, Inc.
72-751529985
In Commercial Distribution

  • 00190776299446 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

CERES - 00840916139995

Rasp, 10 deg, 8&9 mm
SPINAL ELEMENTS
170-2001-10
In Commercial Distribution

  • 00840916139995 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

CERES - 00840916139957

Rasp, 6 deg, 8&9 mm
SPINAL ELEMENTS
170-2001-06
In Commercial Distribution

  • 00840916139957 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

PaediGAV® - 04041906116309

PAEDIGAV SYSTEM W/PRECHAMBER 9/29
Christoph Miethke GmbH & Co. KG
FV287T
Not in Commercial Distribution

  • 04041906116309 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 29.000 CWS
FV287T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906116200

PAEDIGAV SYSTEM W/PRECHAMBER 9/24
Christoph Miethke GmbH & Co. KG
FV286T
Not in Commercial Distribution

  • 04041906116200 ()

  • Pressure rating vert. (cmH2O) : 24.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV286T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906116101

PAEDIGAV SYSTEM W/PRECHAMBER 9/19
Christoph Miethke GmbH & Co. KG
FV285T
Not in Commercial Distribution

  • 04041906116101 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 19.000 CWS
FV285T

  • Ventriculo-peritoneal/atrial shunt

PaediGAV® - 04041906115104

PAEDIGAV WITH DISTAL CATHETER 9/29
Christoph Miethke GmbH & Co. KG
FV275T
In Commercial Distribution

  • 04041906115104 ()

  • Pressure rating horiz. (cmH2O) : 9.000 CWS
  • Pressure rating vert. (cmH2O) : 29.000 CWS
FV275T

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906115005

PAEDIGAV WITH DISTAL CATHETER 9/24
Christoph Miethke GmbH & Co. KG
FV274T
Not in Commercial Distribution

  • 04041906115005 ()

  • Pressure rating vert. (cmH2O) : 24.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV274T

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906114909

PAEDIGAV WITH DISTAL CATHETER 9/19
Christoph Miethke GmbH & Co. KG
FV273T
Not in Commercial Distribution

  • 04041906114909 ()

  • Pressure rating vert. (cmH2O) : 19.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
FV273T

  • Cerebrospinal fluid shunt valve

0412,APS1,08,N,LT(9&11) - 00840828149921

0412,APS1,08,N,LT(9&11)
CURBELL MEDICAL PRODUCTS, INC.
3412-016
In Commercial Distribution

  • 00840828149921 ()
558

  • Pillow speaker

Somnostar - 10846446020274

SWR KIT SSPRO SOFTWARE VER 9
Carefusion Corporation
63734
Not in Commercial Distribution

  • 10846446020274 ()
63734

  • Home-use sleep apnoea recording system
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