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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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inFlow Sizing Device - 00862563003078

Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump

2 Pack, Electrode Delivery Tool Kit - 00852184003618

No Description
Synapse Biomedical, Inc.
20-0074
In Commercial Distribution

  • 00852184003618 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Disposable Electrode Delivery Tool - 00852184003588

No Description
Synapse Biomedical, Inc.
21-0039-99
In Commercial Distribution

  • 00852184003588 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable, White - 00852184003182

No Description
Synapse Biomedical, Inc.
21-0026-99
In Commercial Distribution

  • 00852184003182 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable Yellow - 00852184003175

No Description
Synapse Biomedical, Inc.
21-0025-99
In Commercial Distribution

  • 00852184003175 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable, Orange - 00852184003168

No Description
Synapse Biomedical, Inc.
21-0024-99
In Commercial Distribution

  • 00852184003168 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable, Green - 00852184003151

No Description
Synapse Biomedical, Inc.
21-0023-99
In Commercial Distribution

  • 00852184003151 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Trocar to Transducer Tubing - 00852184003137

No Description
Synapse Biomedical, Inc.
21-0010-99
In Commercial Distribution

  • 00852184003137 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

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 Kit, HDE - 00852184003038

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

  • 00852184003038 ()


  • 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

OrthoMedFlex - M7161111818000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111816000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111815000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111814000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111813000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111812000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111811000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111810000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111809000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0900
In Commercial Distribution

  • M7161111809000 ()
111-18-0900

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111808000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis

Centrifuge Tube 50 mL - 17350025914609

No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube

Centrifuge Tube 15 mL - 17350025914593

No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube

Sample Tube 5 mL - 17350025914579

No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube

Oocyte Collection Tube 14 mL - 17350025914555

No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube

Origin Hip Stem, Coxa Vara - 09348215051914

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1804
In Commercial Distribution

  • 09348215051914 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051907

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1604
In Commercial Distribution

  • 09348215051907 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051891

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1504
In Commercial Distribution

  • 09348215051891 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051884

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1404
In Commercial Distribution

  • 09348215051884 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051877

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1304
In Commercial Distribution

  • 09348215051877 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051860

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1204
In Commercial Distribution

  • 09348215051860 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051853

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1104
In Commercial Distribution

  • 09348215051853 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051846

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1004
In Commercial Distribution

  • 09348215051846 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem, Coxa Vara - 09348215051839

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0904
In Commercial Distribution

  • 09348215051839 ()


  • 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

Origin DAA Stem, Standard Offset - 09348215032487

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0902
In Commercial Distribution

  • 09348215032487 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215032470

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0802
In Commercial Distribution

  • 09348215032470 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023928

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1805
In Commercial Distribution

  • 09348215023928 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023911

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1605
In Commercial Distribution

  • 09348215023911 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023904

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1505
In Commercial Distribution

  • 09348215023904 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023898

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1405
In Commercial Distribution

  • 09348215023898 ()


  • Coated femoral stem prosthesis, modular
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