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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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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

AMARA - 00606959015005

AMARA MASK with STANDARD ELBOW, with RS FRAME, and RS HEADGEAR, INTERNATIONAL, PETITE
Respironics, Inc.
Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,INTL
In Commercial Distribution

  • 00606959015005 ()
1090230

  • CPAP/BPAP face mask, reusable

AF531 - 00606959012349

AF531 Mask with Entrainment Elbow (Nebulizing Elbow), with Four Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with 4 point Headgear, Small, USA
In Commercial Distribution

  • 30606959012340 ()
  • 00606959012349 ()
1094811

  • CPAP/BPAP face mask, single-use

NAMIC - H965800840030

NAMIC Acceler-8 Angiographic 8 ml Control Syringe with Male Luer Lock with Reservoir
NAVILYST MEDICAL, INC.
80084003
In Commercial Distribution

  • H965800840031 ()
  • H965800840030 ()

  • 8 ml


  • Stopcock

NAMIC - H965800830030

NAMIC Saver-7 Angiographic 7 ml Control Syringe with Male Luer Lock with Reservoir
NAVILYST MEDICAL, INC.
80083003
In Commercial Distribution

  • H965800830031 ()
  • H965800830030 ()

  • 7 ml


  • Stopcock

Speedlock - 00848657026260

Grasper, 5mm with Spoon with Ratchet Handle: D1368 Composite On/Off, 34cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R/D1368
In Commercial Distribution

  • 00848657026260 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657026239

Grasper, 5mm with Spoon with Ratchet Handle: 8510-02 Composite French Style, 34cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R/8510-02
In Commercial Distribution

  • 00848657026239 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657026222

Grasper, 5mm with Spoon with Ratchet Handle: 8510-01 Composite Reinforced Safety, 34cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R/8510-01
In Commercial Distribution

  • 00848657026222 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657026192

Grasper, 5mm with Spoon with Ratchet Handle: D1368 Composite On/Off, 45cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-45-R/D1368
In Commercial Distribution

  • 00848657026192 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
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