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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SFLX 4-1 COIL
EBI, LLC
1068236
In Commercial Distribution

  • 00812301020584 ()
1068236

  • Patient-worn bone growth electromagnetic stimulator
SFLX 4 COIL
EBI, LLC
1068235
In Commercial Distribution

  • 00812301020577 ()
1068235

  • Patient-worn bone growth electromagnetic stimulator
BIOMET EBI BONE HEALING SYSTEM
EBI, LLC
1068234
In Commercial Distribution

  • 00812301020560 ()
1068234

  • Patient-worn bone growth electromagnetic stimulator
CONTROLLER ASSEMBLY, REPLACEMENT - BIOMET EBI BONE HEALING SYSTEM
EBI, LLC
1068233
In Commercial Distribution

  • 00812301020553 ()
1068233

  • Patient-worn bone growth electromagnetic stimulator
SFLX 3 COIL
EBI, LLC
1068229
In Commercial Distribution

  • 00812301020546 ()
1068229

  • Patient-worn bone growth electromagnetic stimulator
SFLX 2-4 COIL
EBI, LLC
1068228
In Commercial Distribution

  • 00812301020539 ()
1068228

  • Patient-worn bone growth electromagnetic stimulator
SFLX 2-1 COIL
EBI, LLC
1068227
In Commercial Distribution

  • 00812301020522 ()
1068227

  • Patient-worn bone growth electromagnetic stimulator
SFLX 1 COIL
EBI, LLC
1068225
In Commercial Distribution

  • 00812301020508 ()
1068225

  • Patient-worn bone growth electromagnetic stimulator
SFLX 5 COIL
EBI, LLC
1068224
In Commercial Distribution

  • 00812301020492 ()
1068224

  • Patient-worn bone growth electromagnetic stimulator
CABLE 48 REPLACEMENT PART
EBI, LLC
1068223
In Commercial Distribution

  • 00812301020485 ()
1068223

  • Patient-worn bone growth electromagnetic stimulator
BELT / STRAP REPLACEMENT REPLACEMENT
EBI, LLC
1068222
In Commercial Distribution

  • 00812301020478 ()
1068222

  • Patient-worn bone growth electromagnetic stimulator
CABLE 28 REPLACEMENT PART
EBI, LLC
1068215
In Commercial Distribution

  • 00812301020461 ()
1068215

  • Patient-worn bone growth electromagnetic stimulator
CABLE ZERO INCH REPLACEMENT
EBI, LLC
1068210
In Commercial Distribution

  • 00812301020454 ()
1068210

  • Patient-worn bone growth electromagnetic stimulator
BHS EXTREMITY BAND
EBI, LLC
1068209
In Commercial Distribution

  • 00812301020447 ()
1068209

  • Patient-worn bone growth electromagnetic stimulator
CLIP HOLDER ASSEMBLY
EBI, LLC
1068208
In Commercial Distribution

  • 00812301020430 ()
1068208

  • Patient-worn bone growth electromagnetic stimulator
BATTERY DOOR, BIOMET SPINALPAK REPLACEMENT
EBI, LLC
1067783-2
In Commercial Distribution

  • 00812301020416 ()
1067783-2

  • Patient-worn bone growth electromagnetic stimulator
BATTERY DOOR, BIOMET ORTHOPAK REPLACEMENT
EBI, LLC
1067783-1
In Commercial Distribution

  • 00812301020409 ()
1067783-1

  • Patient-worn bone growth electromagnetic stimulator
AC ADAPTOR, ALTERNATE
EBI, LLC
1067759
In Commercial Distribution

  • 00812301020393 ()
1067759

  • Patient-worn bone growth electromagnetic stimulator
AC ADAPTER KIT
EBI, LLC
1067729
In Commercial Distribution

  • 00812301020386 ()
1067729

  • Patient-worn bone growth electromagnetic stimulator
WALL PLUG ADAPTER KIT
EBI, LLC
1067728-1
In Commercial Distribution

  • 00812301020379 ()
1067728-1

  • Patient-worn bone growth electromagnetic stimulator
AC ADAPTOR, REPLACEMENT
EBI, LLC
1067728
In Commercial Distribution

  • 00812301020362 ()
1067728

  • Patient-worn bone growth electromagnetic stimulator
ORTHOPAK ASSEMBLY - ROW
EBI, LLC
1067727
In Commercial Distribution

  • 00812301020355 ()
1067727

  • Patient-worn bone growth electromagnetic stimulator
SPINALPAK ASSEMBLY - ROW
EBI, LLC
1067725
In Commercial Distribution

  • 00812301020348 ()
1067725

  • Patient-worn bone growth electromagnetic stimulator
72" LEAD WIRES, REPLACEMENT
EBI, LLC
1067724-5
In Commercial Distribution

  • 00812301020331 ()
1067724-5

  • Patient-worn bone growth electromagnetic stimulator
48" LEAD WIRES, REPLACEMENT
EBI, LLC
1067724-4
In Commercial Distribution

  • 00812301020324 ()
1067724-4

  • Patient-worn bone growth electromagnetic stimulator
30" LEAD WIRES, REPLACEMENT
EBI, LLC
1067724-3
In Commercial Distribution

  • 00812301020317 ()
1067724-3

  • Patient-worn bone growth electromagnetic stimulator
20" LEAD WIRES, REPLACEMENT
EBI, LLC
1067724-2
In Commercial Distribution

  • 00812301020300 ()
1067724-2

  • Patient-worn bone growth electromagnetic stimulator
12" LEAD WIRES, REPLACEMENT
EBI, LLC
1067724-1
In Commercial Distribution

  • 00812301020294 ()
1067724-1

  • Patient-worn bone growth electromagnetic stimulator
EXTREMITY BAND, REPLACEMENT
EBI, LLC
1067723
In Commercial Distribution

  • 00812301020287 ()
1067723

  • Patient-worn bone growth electromagnetic stimulator
STIMULATOR HOLSTER, REPLACEMENT
EBI, LLC
1067722
In Commercial Distribution

  • 00812301020270 ()
1067722

  • Patient-worn bone growth electromagnetic stimulator
BATTERY PACK CHARGER, REPLACEMENT
EBI, LLC
1067721
In Commercial Distribution

  • 00812301020263 ()
1067721

  • Patient-worn bone growth electromagnetic stimulator
BATTERY PACK, REPLACEMENT
EBI, LLC
1067720
In Commercial Distribution

  • 00812301020256 ()
1067720

  • Patient-worn bone growth electromagnetic stimulator
ORTHOPAK STIMULATOR, BIOMET
EBI, LLC
1067719
In Commercial Distribution

  • 00812301020249 ()
1067719

  • Patient-worn bone growth electromagnetic stimulator
ORTHOPAK ASSEMBLY
EBI, LLC
1067718
In Commercial Distribution

  • 00812301020232 ()
1067718

  • Patient-worn bone growth electromagnetic stimulator
SPINALPAK STIMULATOR, BIOMET
EBI, LLC
1067717
In Commercial Distribution

  • 00812301020225 ()
1067717

  • Patient-worn bone growth electromagnetic stimulator
SPINALPAK ASSEMBLY
EBI, LLC
1067716
In Commercial Distribution

  • 00812301020218 ()
1067716

  • Patient-worn bone growth electromagnetic stimulator
ELECTRODE COVER PATCHES
EBI, LLC
106130-17
In Commercial Distribution

  • 00812301020195 ()
106130-17

  • Patient-worn bone growth electromagnetic stimulator
SPF-PLUS 60/W Implantable Spinal Fusion Stimulator
EBI, LLC
10-1398W
In Commercial Distribution

  • 00812301020133 ()
10-1398W

  • Patient-worn bone growth electromagnetic stimulator
SPF-PLUS 60/M Implantable Spinal Fusion Stimulator
EBI, LLC
10-1398M
In Commercial Distribution

  • 00812301020126 ()
10-1398M

  • Patient-worn bone growth electromagnetic stimulator
OSTEOGEN-40/S
EBI, LLC
10-1348S
In Commercial Distribution

  • 00812301020119 ()
10-1348S

  • Patient-worn bone growth electromagnetic stimulator
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