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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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AMARA GEL - 00606959025226

AMARA GEL MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, PETITE, INTERNATIONAL
Respironics, Inc.
AMARA GEL MASK SE WITH RS FRAME AND HEADGEAR INTL, PETITE
In Commercial Distribution

  • 00606959025226 ()
1090430

  • CPAP/BPAP face mask, reusable

AF541 - 00606959024557

AF541 Mask with Entrainment Elbow, Leak 2, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH 4-POINT HEADGEAR, X-LARGE
In Commercial Distribution

  • 30606959024558 ()
  • 00606959024557 ()
1121069

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024472

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, X-Large
In Commercial Distribution

  • 30606959024473 ()
  • 00606959024472 ()
1121491

  • CPAP/BPAP face mask, single-use

Typenex Wound Drainage - 00812269031363

Kit with 400 ml Spring Reservoir and 19 FR Perforated Round, with Trocar
TYPENEX MEDICAL LLC
WD0704TK5
In Commercial Distribution

  • 00812269031370 ()
  • 00812269031363 ()


  • Closed-wound drainage kit

Typenex Wound Drainage - 00812269031349

Kit with 400 ml Spring Reservoir and 15 FR Perforated Round, with Trocar
TYPENEX MEDICAL LLC
WD0703TK5
In Commercial Distribution

  • 00812269031349 ()
  • 00812269031356 ()


  • Closed-wound drainage kit

Typenex Wound Drainage - 00812269031325

Kit with 400 ml Spring Reservoir and 10 FR Perforated Round, with Trocar
TYPENEX MEDICAL LLC
WD0702TK5
In Commercial Distribution

  • 00812269031332 ()
  • 00812269031325 ()


  • Closed-wound drainage kit

Millennium - 00190776373023

Kellan Capsulorhexis Forceps, with Arruga Style Tips, Round Knurled Handle with Guide Pin
Avalign Technologies, Inc.
92-F2511
In Commercial Distribution

  • 00190776373023 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

MILEX - 60888937009066

KIT: Ring with support with knob folding Pessary #12; 4 3/4" (121mm)
Coopersurgical, Inc.
MXKPRSK12
In Commercial Distribution

  • 60888937009066 ()


  • Pelvic-organ-supporting pessary

MILEX - 60888937009059

KIT: Ring with support with knob folding Pessary #11; 4 1/2" (114mm)
Coopersurgical, Inc.
MXKPRSK11
In Commercial Distribution

  • 60888937009059 ()


  • Pelvic-organ-supporting pessary

MILEX - 60888937009042

KIT: Ring with support with knob folding Pessary #10; 4 1/4" (108mm)
Coopersurgical, Inc.
MXKPRSK10
In Commercial Distribution

  • 60888937009042 ()


  • Pelvic-organ-supporting pessary
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