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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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AF531 - 00606959012387

AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Medium, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012388 ()
  • 00606959012387 ()
1094815

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012332

AF531 Mask with Standard Elbow, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 Point Headgear, Large, USA
In Commercial Distribution

  • 30606959012333 ()
  • 00606959012332 ()
1094810

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012325

AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012318

AF531 Mask with Standard Elbow, with 4 Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, Small, USA
In Commercial Distribution

  • 30606959012319 ()
  • 00606959012318 ()
1094808

  • CPAP/BPAP face mask, single-use

Speedlock - 00848657004732

Speedlock Needle Holder, 5mm, tapered jaw with TC inserts with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8516-00-R
In Commercial Distribution

  • 00848657004732 ()


  • Suturing needle holder, reusable

Speedlock - 00848657005784

US Babcock, with spring tension, flexible and atraumatic, 10mm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-13-R
In Commercial Distribution

  • 00848657005784 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Speedlock - 00848657001427

Speedlock Biopsy Spoon, 5mm, with teeth double action, 45cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-10-45-R
In Commercial Distribution

  • 00848657001427 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Oxygen Accessory - 00848530106034

Everflo Pressure Regulator Adapter with Hose Compatible with all EverFlo Models
SUNSET HEALTHCARE SOLUTIONS, INC.
RP034
In Commercial Distribution

  • 10848530106031 ()
  • 00848530106034 ()


  • Non-fixed medical gas distribution line regulator

MICASEPT BIOPSY AND GRASPING FORCEPS - 00192896008519

MICASEPT BIOPSY AND GRASPING FORCEPS WITH 2 FANGS WITH ROUND RATCHET
SONTEC INSTRUMENTS, INC.
20920-06
In Commercial Distribution


  • Lumen/Inner Diameter: 4.5 Millimeter
  • Length: 300 Millimeter
20920-06

  • Rigid endoscopic biopsy forceps, reusable

HOOK RETRACTOR - 00192896042384

HOOK RETRACTOR WITH THUMB RING MINIATURE MODEL WITH FOUR IN-LINE PRONGS
SONTEC INSTRUMENTS, INC.
475-518
In Commercial Distribution

  • 00192896042384 ()

  • Length: 4.5 Inch
475-518

  • Hand-held surgical retractor, reusable
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