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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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Adjustable height shower head, chrome
WATER PIK, INC.
ASW-673E
In Commercial Distribution

  • 00073950247757 ()
ASW-673E

  • External manual massager, home-use
Hunstad Infiltration Handle with Spring
MENTOR TEXAS L.P.
HUN-HAN-S
In Commercial Distribution

  • 00081317023197 ()
HUN-HAN-S

  • Surgical irrigation/aspiration tubing set
Grooved Director With Tongue Tie Stainless Steel
SONTEC INSTRUMENTS, INC.
197-691
In Commercial Distribution

  • 00192896107908 ()

  • Length: 5 Inch
197-691

  • Gastro-urological director
BAYONETTE TURBINATE ELECTRODE WITH HP
Cynosure, LLC
IEC-I6D
In Commercial Distribution

  • 00841494102036 ()
IEC-I6D

  • Open-surgery electrosurgical electrode, monopolar, reusable
No Description
MAXILL, INC.
6070541128
In Commercial Distribution

  • D89260705411282 ()
  • D89260705411281 ()
  • D89260705411283 ()
  • D89260705411280 ()


  • Dental floss
Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK2030NC2 ()
  • H862TIVK2030NC1 ()
  • H862TIVK2030NC0 ()

  • Length: 94 Centimeter
TIVK2030

  • Valvulotome, percutaneous
Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK20302 ()
  • H862TIVK20301 ()
  • H862TIVK20300 ()

  • Length: 94 Centimeter
TIVK2030

  • Vein stripper, single-use
Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH40NC2 ()
  • H862TIVH40NC1 ()
  • H862TIVH40NC0 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Valvulotome, percutaneous
Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH402 ()
  • H862TIVH401 ()
  • H862TIVH400 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Vein stripper, single-use
Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH30NC2 ()
  • H862TIVH30NC1 ()
  • H862TIVH30NC0 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Valvulotome, percutaneous
Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH302 ()
  • H862TIVH301 ()
  • H862TIVH300 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Vein stripper, single-use
Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH20NC2 ()
  • H862TIVH20NC1 ()
  • H862TIVH20NC0 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous
Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVCNC2 ()
  • H862TIVCNC1 ()
  • H862TIVCNC0 ()

  • Length: 94 Centimeter
TIVC

  • Valvulotome, percutaneous
Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVC2 ()
  • H862TIVC1 ()
  • H862TIVC0 ()

  • Length: 94 Centimeter
TIVC

  • Vein stripper, single-use
BELLOW BLUE WITH VENTIL AND CONNECTION M8
SONTEC INSTRUMENTS, INC.
04-11020-10
In Commercial Distribution



  • ENT powder applicator
No Description
INVACARE CORPORATION
TDXSP2
Not in Commercial Distribution

  • 00841447100911 ()


  • Electric-motor-driven wheelchair, occupant-controlled
No Description
Eckert & Ziegler BEBIG GmbH
LAZ22-01
Not in Commercial Distribution

  • 04049223106195 ()
LAZ22-01

  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Anterior Lumbar Cage
Baat Medical Products B.V.
Fortilink®-SA
In Commercial Distribution

  • 08720246789980 ()
68-A-3627-12-20L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789973 ()
68-A-3627-18-14L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789966 ()
68-A-3627-16-14L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789959 ()
68-A-3627-14-14L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789942 ()
68-A-3627-12-14L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789935 ()
68-A-3627-10-14L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789928 ()
68-A-3627-18-8L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789911 ()
68-A-3627-16-8L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789904 ()
68-A-3627-14-8L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789898 ()
68-A-3627-12-8L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789881 ()
68-A-3627-10-8L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789874 ()
68-A-3225-22-30L

  • Metallic spinal interbody fusion cage
No Description
Baat Medical Products B.V.
Fortilink®-TS
In Commercial Distribution

  • 08720246789867 ()
68-A-3225-20-30L

  • Metallic spinal interbody fusion cage
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