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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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EMA Now - 00842326101166

Full kit with all components
The Myerson Company Limited
EMANOW21
In Commercial Distribution

  • 00842326101166 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100541

EMA Kit4 with 120mmx2.5mm disc
The Myerson Company Limited
EMAKT12010
In Commercial Distribution

  • 00842326100541 ()

  • Height: 2.5 Millimeter
  • Outer Diameter: 120 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100534

EMA Kit3 with 120mmx2.0mm disc
The Myerson Company Limited
EMAKT12008
In Commercial Distribution

  • 00842326100534 ()

  • Height: 2.0 Millimeter
  • Outer Diameter: 120 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100527

EMA Kit2 with 125mmx2.5mm disc
The Myerson Company Limited
EMAKT12510
In Commercial Distribution

  • 00842326100527 ()

  • Height: 2.5 Millimeter
  • Outer Diameter: 125 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100510

EMA Kit1 with 125mmx2.0mm disc
The Myerson Company Limited
EMAKT12508
In Commercial Distribution

  • 00842326100510 ()

  • Height: 2.0 Millimeter
  • Outer Diameter: 125 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

ACIF Interbody System Instruments - M6950CR0001210

Cervical Inserter with Impaction Cap
Tyber Medical LLC
0CR-000121
In Commercial Distribution

  • M6950CR0001210 ()
0CR-000121

  • Metal-polymer composite spinal interbody fusion cage

Blizzard Casualty Blanket XL + Heat pads - M689BH01020

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

Blizzard Casualty Blanket XL + Heat pads - M689BH01010

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689BH01010 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

OptiChamber Diamond - 00383730000527

DIAMOND WITH MED MASK-PREFERRED PLUS
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730000527 ()
1103038

  • Medicine chamber spacer, reusable

OptiChamber Diamond - 00383730000510

DIAMOND WITH LG MASK-PREFERRED PLUS
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730000510 ()
1103007

  • Medicine chamber spacer, reusable
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