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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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SURGENTEC, LLC
ONP-S-10
In Commercial Distribution

  • 00858406007204 ()


  • Synthetic bone graft
Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE braided suture, two thermoplastic tip covers
ZIPTEK LLC
Rb41-S-4
In Commercial Distribution

  • 00858816006064 ()
64

  • Tendon/ligament bone anchor, bioabsorbable
Delivery Sheath
EBR Systems, Inc.
2000
In Commercial Distribution

  • 00859244007067 ()


  • Left-ventricular wireless pacing system transducer/electrode
Receiver Electrode Delivery Catheter
EBR Systems, Inc.
1000
In Commercial Distribution

  • 00859244007043 ()


  • Left-ventricular wireless pacing system transducer/electrode
Battery
EBR Systems, Inc.
3100
In Commercial Distribution

  • 00859244007029 ()


  • Implantable pacemaker battery
Transmitter
EBR Systems, Inc.
4100
In Commercial Distribution

  • 00859244007005 ()


  • Left-ventricular wireless pacing system sensor/transmitter
BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
CVRX, INC.
1037
In Commercial Distribution

  • 00859144004470 ()
100063-222

  • Baroreceptor electrical stimulation system
BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
CVRX, INC.
1036
In Commercial Distribution

  • 00859144004463 ()
100063-212

  • Baroreceptor electrical stimulation system
Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004456 ()
100056-202

  • Baroreceptor electrical stimulation system
Model 9010 Programmer System (US Commercial)
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004449 ()
100055-202

  • Baroreceptor electrical stimulation system
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