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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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Origin DAA Stem, Standard Offset - 09348215088439

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1112
In Commercial Distribution

  • 09348215088439 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088422

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1013
In Commercial Distribution

  • 09348215088422 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088415

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1012
In Commercial Distribution

  • 09348215088415 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088408

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0913
In Commercial Distribution

  • 09348215088408 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088392

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0912
In Commercial Distribution

  • 09348215088392 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088385

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0813
In Commercial Distribution

  • 09348215088385 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088378

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0812
In Commercial Distribution

  • 09348215088378 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215083533

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0805
In Commercial Distribution

  • 09348215083533 ()


  • Coated femoral stem prosthesis, modular

Origin Short 125deg Trial Neck - 09348215081423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck HO - 09348215055790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck SO - 09348215055783

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable

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 - 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

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

Xpert Flu - 07332940001070

Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

OrthoMedFlex - M7161111818010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1801
In Commercial Distribution

  • M7161111818010 ()
111-18-1801

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111816010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1601
In Commercial Distribution

  • M7161111816010 ()
111-18-1601

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111815010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1501
In Commercial Distribution

  • M7161111815010 ()
111-18-1501

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111814010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111813010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111812010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1201
In Commercial Distribution

  • M7161111812010 ()
111-18-1201

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111811010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1101
In Commercial Distribution

  • M7161111811010 ()
111-18-1101

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111810010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1001
In Commercial Distribution

  • M7161111810010 ()
111-18-1001

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111809010

Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0901
In Commercial Distribution

  • M7161111809010 ()
111-18-0901

  • Press-fit femoral stem prosthesis

Smoke Shark III - 10845854600092

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 - 10845854600085

Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system

MINIVAC - 10845854053102

MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

ECVV220

  • Surgical plume evacuation system

MINIVAC - 10845854053096

MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 10845854053096 ()
  • 30845854053090 ()
ECVV120

  • Surgical plume evacuation system

ACU-EVAC - 00814105021668

TX NOZZLE STARTER KIT PACK, EVAC HOSE 9"" 5/PER BAG
ACUDERM, INC.
TXPACK-1
In Commercial Distribution

  • 00814105021668 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020586

Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop
ACUDERM, INC.
CTFEET
In Commercial Distribution

  • 00814105020586 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020579

Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator
ACUDERM, INC.
CMB
In Commercial Distribution

  • 00814105020579 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020562

Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel
ACUDERM, INC.
DUALCART
In Commercial Distribution

  • 00814105020562 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020555

Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
ACUDERM, INC.
EWMB
In Commercial Distribution

  • 00814105020555 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020548

Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
ACUDERM, INC.
PFTSW
In Commercial Distribution

  • 00814105020548 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020531

Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use with lasers.
ACUDERM, INC.
ARM
In Commercial Distribution

  • 00814105020531 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020524

Hose connector used to connect TX Pack or LTX Pack to hose
ACUDERM, INC.
HOSECON
In Commercial Distribution

  • 00814105020524 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020517

6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020487

Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • Surgical plume evacuation system

ACU-EVAC - 00814105020470

Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke.
ACUDERM, INC.
M1-FILTER
In Commercial Distribution

  • 00814105020470 ()


  • Surgical plume evacuation system
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