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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Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200050
Not in Commercial Distribution

  • 08714729877806 ()

  • 7 F Diameter
  • 2.33 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200030
Not in Commercial Distribution

  • 08714729877783 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200020
Not in Commercial Distribution

  • 08714729877776 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200010
Not in Commercial Distribution

  • 08714729877769 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004R5031TH0
In Commercial Distribution

  • 08714729963974 ()

  • 7 F Diameter
  • 2.33 mm Diameter
  • 4 mm Length
M004R5031TH0

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004R5031THK20
In Commercial Distribution

  • 08714729963950 ()

  • 2.33 mm Diameter
  • 7 F Diameter
  • 4 mm Length
M004R5031THK20

  • Cardiac radio-frequency ablation system catheter
30cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-30
In Commercial Distribution

  • 08714729771180 ()

  • 30 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
70cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70
In Commercial Distribution

  • 08714729767749 ()

  • 70 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
50cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-50
In Commercial Distribution

  • 08714729767725 ()

  • 50 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 8 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012834 ()
  • 28056865012838 ()
0120083

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 8 UPPER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012827 ()
  • 28056865012821 ()
0120082

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012810 ()
  • 18056865012817 ()
0120081

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 UPPER
Not in Commercial Distribution

  • 08056865012803 ()
  • 28056865012906 ()
  • 18056865012800 ()
0120080

  • Resin artificial teeth
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

  • Area/Surface Area: 250 Square millimeter
10-0609

  • Glaucoma shunt, tubular, non-animal-derived
CUSTOM ADAPTER-BARD/ST.JUDE 10 LD
GRAPHIC CONTROLS ACQUISITION CORP
St Jude Medical
In Commercial Distribution

  • 03700506307104 ()
IPC73745

  • Patient monitoring system module, electrocardiographic
No Description
BIOTRONIK SE & Co. KG
346367
Not in Commercial Distribution

  • 04035479077853 ()

  • Length: 60 cm
  • Max. Diameter: 2.2 mm
346367

  • Endocardial/interventricular septal pacing lead
No Description
BIOTRONIK SE & Co. KG
346366
Not in Commercial Distribution

  • 04035479077846 ()

  • Length: 53 cm
  • Max. Diameter: 2.2 mm
346366

  • Endocardial/interventricular septal pacing lead
Ø5/ L=15
Megagen Implant Co. Ltd
ST5015
In Commercial Distribution

  • 08806388236954 ()
ST5015C

  • Screw endosteal dental implant, two-piece
Ø5/ L=13
Megagen Implant Co. Ltd
ST5013
In Commercial Distribution

  • 08806388236947 ()
ST5013C

  • Screw endosteal dental implant, two-piece
Ø5/ L=11.5
Megagen Implant Co. Ltd
ST5011
In Commercial Distribution

  • 08806388236930 ()
ST5011C

  • Screw endosteal dental implant, two-piece
Ø5/ L=10
Megagen Implant Co. Ltd
ST5010
In Commercial Distribution

  • 08806388236923 ()
ST5010C

  • Screw endosteal dental implant, two-piece
Ø5/ L=8.5
Megagen Implant Co. Ltd
ST5008
In Commercial Distribution

  • 08806388236916 ()
ST5008C

  • Screw endosteal dental implant, two-piece
Ø5/ L=7
Megagen Implant Co. Ltd
ST5007
In Commercial Distribution

  • 08806388236909 ()
ST5007C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=15
Megagen Implant Co. Ltd
ST4515
In Commercial Distribution

  • 08806388236893 ()
ST4515C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=13
Megagen Implant Co. Ltd
ST4513
In Commercial Distribution

  • 08806388236886 ()
ST4513C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=11.5
Megagen Implant Co. Ltd
ST4511
In Commercial Distribution

  • 08806388236879 ()
ST4511C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=10
Megagen Implant Co. Ltd
ST4510
In Commercial Distribution

  • 08806388236862 ()
ST4510C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=8.5
Megagen Implant Co. Ltd
ST4508
In Commercial Distribution

  • 08806388236855 ()
ST4508C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=7
Megagen Implant Co. Ltd
ST4507
In Commercial Distribution

  • 08806388236848 ()
ST4507C

  • Screw endosteal dental implant, two-piece
Ø4/ L=15
Megagen Implant Co. Ltd
ST4015
In Commercial Distribution

  • 08806388236831 ()
ST4015C

  • Screw endosteal dental implant, two-piece
Ø4/ L=13
Megagen Implant Co. Ltd
ST4013
In Commercial Distribution

  • 08806388236824 ()
ST4013C

  • Screw endosteal dental implant, two-piece
Ø4/ L=11.5
Megagen Implant Co. Ltd
ST4011
In Commercial Distribution

  • 08806388236817 ()
ST4011C

  • Screw endosteal dental implant, two-piece
Ø4/ L=10
Megagen Implant Co. Ltd
ST4010
In Commercial Distribution

  • 08806388236800 ()
ST4010C

  • Screw endosteal dental implant, two-piece
Ø4/ L=8.5
Megagen Implant Co. Ltd
ST4008
In Commercial Distribution

  • 08806388236794 ()
ST4008C

  • Screw endosteal dental implant, two-piece
Ø4/ L=7
Megagen Implant Co. Ltd
ST4007
In Commercial Distribution

  • 08806388236787 ()
ST4007C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=15
Megagen Implant Co. Ltd
ST3515
In Commercial Distribution

  • 08806388236770 ()
ST3515C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=13
Megagen Implant Co. Ltd
ST3513
In Commercial Distribution

  • 08806388236763 ()
ST3513C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=11.5
Megagen Implant Co. Ltd
ST3511
In Commercial Distribution

  • 08806388236756 ()
ST3511C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=10
Megagen Implant Co. Ltd
ST3510
In Commercial Distribution

  • 08806388236749 ()
ST3510C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=8.5
Megagen Implant Co. Ltd
ST3508
In Commercial Distribution

  • 08806388236732 ()
ST3508C

  • Screw endosteal dental implant, two-piece
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114254 ()

  • 17x10x32mm
TST20171032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114247 ()

  • 16x10x32mm
TST20161032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114230 ()

  • 15x10x32mm
TST20151032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114179 ()

  • 18x10x32mm
TST16181032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114162 ()

  • 18x10x32mm
TST20181032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114155 ()

  • 16x10x32mm
TST16161032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114148 ()

  • 15x10x32mm
TST16151032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114131 ()

  • 17x10x32mm
TST16171032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114094 ()

  • 18x10x32mm
TST12181032

  • Metallic spinal interbody fusion cage
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