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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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Curaplex - 00812277033595

Airway Supraglottic LTS-D #5 Kit
BOUND TREE MEDICAL, LLC
KLTSD405K-NG
In Commercial Distribution

  • 00812277033595 ()
  • 00810094573577 ()
KLTSD405K-NG

  • Laryngeal mask airway, single-use

Curaplex - 00812277033526

Airway Kit Guedel Sizes 0-5
BOUND TREE MEDICAL, LLC
SEEGAK
In Commercial Distribution

  • 00812277033526 ()
  • 00810094573355 ()
SEEGAK

  • Laryngeal mask airway, single-use

Provox® FreeHands HME® Flow - 07331791008399

Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.
Atos Medical AB
Flow
Not in Commercial Distribution

  • 07331791008399 ()
  • 07331791010620 ()
8223

  • Tracheostomy tube speech valve

Provox® FreeHands HME® Moist - 07331791008382

Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.
Atos Medical AB
Moist
Not in Commercial Distribution

  • 07331791008382 ()
  • 07331791010613 ()
8222

  • Tracheostomy tube speech valve

Provox FreeHands HME Flow (30 pcs) - 07331791008375

Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.
Atos Medical AB
8221
In Commercial Distribution

  • 07331791008375 ()
  • 07331791010620 ()
  • 07331791017803 ()
8221

  • Tracheostoma protective filter

Provox FreeHands HME Moist (30 pcs) - 07331791008368

Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.
Atos Medical AB
8220
In Commercial Distribution

  • 07331791008368 ()
  • 07331791010613 ()
  • 07331791017797 ()
8220

  • Tracheostoma protective filter

DINAMIC T HUMERUS - 08032909629749

No Description
CITIEFFE SRL
Fracture alignment and guide wire exchange tool
In Commercial Distribution

  • 08032909629749 ()
DT070015

  • Orthopaedic bone-fragment manipulator, reusable

Provox NID 20, 18 mm - 07331791000386

Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Atos Medical AB
7116
In Commercial Distribution

  • 07331791000386 ()

  • Length: 18 Millimeter
7116

  • Tracheoesophageal speech valve, non-indwelling

Provox NID 20, 12 mm - 07331791000362

Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Atos Medical AB
7114
In Commercial Distribution

  • 07331791000362 ()

  • Length: 12 Millimeter
7114

  • Tracheoesophageal speech valve, non-indwelling

Provox NID 20, 14 mm - 07331791000379

Provox NID is a non-indwelling voice prosthesis for patients who are capable of handling the exchange and maintenance of a voice prosthesis independently of a clinician or physician.
Atos Medical AB
7115
In Commercial Distribution

  • 07331791000379 ()

  • Length: 14 Millimeter
7115

  • Tracheoesophageal speech valve, non-indwelling
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