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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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STERILE Blue Cable Set - 00852184003120

No Description
Synapse Biomedical, Inc.
21-0009-99
In Commercial Distribution

  • 00852184003120 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Lead Tunnelers - 00852184003113

No Description
Synapse Biomedical, Inc.
21-0007-99
In Commercial Distribution

  • 00852184003113 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Site Start-up Kit - 00852184003083

No Description
Synapse Biomedical, Inc.
20-0039
In Commercial Distribution

  • 00852184003083 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, ALS CE - 00852184003076

No Description
Synapse Biomedical, Inc.
20-0064
In Commercial Distribution

  • 00852184003076 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, CE 2 EPG - 00852184003069

No Description
Synapse Biomedical, Inc.
20-0063
In Commercial Distribution

  • 00852184003069 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Patient Kit, 1 EPG - 00852184003052

No Description
Synapse Biomedical, Inc.
20-0046
In Commercial Distribution

  • 00852184003052 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS Patient Kit - 00852184003045

No Description
Synapse Biomedical, Inc.
20-0036
In Commercial Distribution

  • 00852184003045 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Kit, HDE - 00852184003038

No Description
Synapse Biomedical, Inc.
20-0028
In Commercial Distribution

  • 00852184003038 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit, ALS CE - 00852184003021

No Description
Synapse Biomedical, Inc.
20-0031
In Commercial Distribution

  • 00852184003021 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ System Kit - 00852184003014

No Description
Synapse Biomedical, Inc.
20-0030
In Commercial Distribution

  • 00852184003014 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx Diaphragm Pacing System - 00852184003007

No Description
Synapse Biomedical, Inc.
20-0035
In Commercial Distribution

  • 00852184003007 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

INTERA - 00850014110147

Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable

BioRef-DC - 07290017249049

BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Origin Coxa Vara Hip Stem - 09348215013226

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1804
In Commercial Distribution

  • 09348215013226 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013219

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1604
In Commercial Distribution

  • 09348215013219 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013202

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1504
In Commercial Distribution

  • 09348215013202 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013196

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1404
In Commercial Distribution

  • 09348215013196 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013189

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1304
In Commercial Distribution

  • 09348215013189 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013172

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1204
In Commercial Distribution

  • 09348215013172 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013165

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1104
In Commercial Distribution

  • 09348215013165 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013158

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1004
In Commercial Distribution

  • 09348215013158 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013141

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0904
In Commercial Distribution

  • 09348215013141 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032562

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1802
In Commercial Distribution

  • 09348215032562 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032555

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1602
In Commercial Distribution

  • 09348215032555 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032548

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1502
In Commercial Distribution

  • 09348215032548 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032531

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1402
In Commercial Distribution

  • 09348215032531 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032524

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1302
In Commercial Distribution

  • 09348215032524 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032517

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1202
In Commercial Distribution

  • 09348215032517 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032500

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1102
In Commercial Distribution

  • 09348215032500 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032494

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1002
In Commercial Distribution

  • 09348215032494 ()


  • Coated femoral stem prosthesis, modular
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