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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No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP08X-000
In Commercial Distribution

  • 00841823107626 ()
SD06R-SP08X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP05X-0MC
In Commercial Distribution

  • 00841823107619 ()
SD06R-SP05X-0MC

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP05X-0LA
In Commercial Distribution

  • 00841823107602 ()
SD06R-SP05X-0LA

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-AP58X-000
In Commercial Distribution

  • 00841823107589 ()
SD06R-AP58X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD05R-SP45X-0T0
In Commercial Distribution

  • 00841823107572 ()
SD05R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD04R-SP45X-000
In Commercial Distribution

  • 00841823107558 ()
SD04R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD04R-AP25X-000
In Commercial Distribution

  • 00841823107503 ()
SD04R-AP25X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD048-SP07X-A00
In Commercial Distribution

  • 00841823107480 ()
SD048-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD047-SP07X-A00
In Commercial Distribution

  • 00841823107473 ()
SD047-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD046-SP07X-A00
In Commercial Distribution

  • 00841823107466 ()
SD046-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD044-SP07X-A00
In Commercial Distribution

  • 00841823107442 ()
SD044-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD042-SP07X-A00
In Commercial Distribution

  • 00841823107428 ()
SD042-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD041-SP07X-A00
In Commercial Distribution

  • 00841823107411 ()
SD041-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD02R-AP58X-000
In Commercial Distribution

  • 00841823107404 ()
SD02R-AP58X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP08X-000
In Commercial Distribution

  • 00841823107299 ()
RD10R-SP08X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP07X-000
In Commercial Distribution

  • 00841823107282 ()
RD10R-SP07X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP05X-0ME
In Commercial Distribution

  • 00841823107268 ()
RD10R-SP05X-0ME

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD08R-SP05X-000
In Commercial Distribution

  • 00841823107220 ()
RD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD06R-SP05X-000
In Commercial Distribution

  • 00841823107206 ()
RD06R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
AD08R-SP05X-000
In Commercial Distribution

  • 00841823100412 ()
AD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
AD06R-SP05X-000
In Commercial Distribution

  • 00841823100405 ()
AD06R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
AD04R-SP10X-000
In Commercial Distribution

  • 00841823100399 ()
AD04R-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
LD14R-SP05X-000
In Commercial Distribution

  • 00841823104236 ()
LD14R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP45X-000
In Commercial Distribution

  • 00841823104212 ()
LD10R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
LD10R-SP05X-000
In Commercial Distribution

  • 00841823104205 ()
LD10R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
LD12R-SP05X-000
In Commercial Distribution

  • 00841823104229 ()
LD12R-SP05X-000

  • Depth electrode
VENTURA NM GRAFT PACKER
SEASPINE ORTHOPEDICS CORPORATION
SR-0229
In Commercial Distribution

  • 10889981157609 ()
SR-0229

  • Bone graft packing block
Shoreline/Admiral Graft Packer
SEASPINE ORTHOPEDICS CORPORATION
SR-0755
In Commercial Distribution

  • 10889981285364 ()
SR-0755

  • Bone graft packing block
No Description
Synapse Biomedical, Inc.
20-0040
In Commercial Distribution

  • 00852184003267 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Extractor Block
SEASPINE ORTHOPEDICS CORPORATION
92-0126
In Commercial Distribution

  • 10889981086763 ()
92-0126

  • Bone graft packing block
Gamma Camera System
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution

  • 05711665004009 ()

  • Weight: 252 Kilogram
  • Height: 173 Centimeter
  • Depth: 138 Centimeter
  • Width: 70 Centimeter
9SOL2210

  • Mobile gamma camera system
No Description
Synapse Biomedical, Inc.
23-0010
In Commercial Distribution

  • 00852184003496 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system
Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system
Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual
Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system
Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system
No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Synapse Biomedical, Inc.
22-0009
In Commercial Distribution

  • 00852184003359 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Packing Block
SEASPINE ORTHOPEDICS CORPORATION
86-0072
In Commercial Distribution

  • 10889981143336 ()
86-0072

  • Bone graft packing block
Implant Assembly/Packing block
SEASPINE ORTHOPEDICS CORPORATION
86-0070
In Commercial Distribution

  • 10889981127121 ()
86-0070

  • Bone graft packing block
Graft Packing Block 30mm x 24mm x XXmm
SEASPINE ORTHOPEDICS CORPORATION
93-6116
In Commercial Distribution

  • 10889981091392 ()

  • 30mm x 24mm x XXmm
93-6116

  • Bone graft packing block
Graft Packing Block, 26mm
SEASPINE ORTHOPEDICS CORPORATION
93-6115
In Commercial Distribution

  • 10889981091385 ()

  • 26mm
93-6115

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3157
In Commercial Distribution

  • 10889981088309 ()
93-3157

  • Bone graft packing block
Pacifica Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3155
In Commercial Distribution

  • 10889981088286 ()
93-3155

  • Bone graft packing block
Pacifica-S Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-3156
In Commercial Distribution

  • 10889981088293 ()
93-3156

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-4157
In Commercial Distribution

  • 10889981089917 ()
93-4157

  • Bone graft packing block
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Screwdriver
In Commercial Distribution

  • 07290114061308 ()
365-000015-00

  • Depth electrode
TLIF Graft Packing Block
CURITEVA, INC.
C405-700
In Commercial Distribution

  • B648C4057000 ()


  • Bone graft packing block
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