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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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XL Sterilization Basket 13" x 24" x 4", 1/8" perforations on bottom & outside handles
Hayden Medical, Inc.
HB20-1324
In Commercial Distribution

  • 00840319715765 ()
HB20-1324

  • Device sterilization/disinfection container, reusable
USA Elite System Standard Flow Resectoscope Standard Sheath 24 Fr (8 mm), Color Coded Yellow
Gyrus ACMI, LLC
REXESRS-24
In Commercial Distribution

  • 00821925008380 ()


  • Endoscope sheath, reusable
USA Elite System Standard Resectoscope Berry Rotating Sheath 24 Fr, (8 mm) Color Coded Yellow
Gyrus ACMI, LLC
EBRS-24
In Commercial Distribution

  • 00821925001329 ()


  • Endoscope sheath, reusable
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 65 - 90mm, 0/24 DEGREES
Medos International Sàrl
188912565
Not in Commercial Distribution

  • 10705034160580 ()
188912565

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 51 - 71mm, 0/24 DEGREES
Medos International Sàrl
188912551
Not in Commercial Distribution

  • 10705034160573 ()
188912551

  • Metallic spinal interbody fusion cage
X-MESH EXPANDABLE CAGE SYSTEM EXPANDABLE VERTEBRAL BODY REPLACEMENT, ANTERIOR, LARGE 40 - 56mm, 0/24 DEGREES
Medos International Sàrl
188912540
Not in Commercial Distribution

  • 10705034160566 ()
188912540

  • Metallic spinal interbody fusion cage
USA Elite System Standard Flow Resectoscope Visual Obturator 24 Fr, (8 mm) Color Coded Yellow
Gyrus ACMI, LLC
EVOR-24
In Commercial Distribution

  • 00821925003712 ()


  • Rigid endoscope obturator
USA Elite System Standard Flow Resectoscope Standard Sheath, 24 Fr (8 mm) Color Coded Yellow
Gyrus ACMI, LLC
ESRS-24
In Commercial Distribution

  • 00821925003194 ()


  • Endoscope sheath, reusable
USA Elite System Continuous Flow Resectoscope Timberlake Obturator 24 Fr, (8 mm) Color Coded Yellow
Gyrus ACMI, LLC
ETOR-24
In Commercial Distribution

  • 00821925002807 ()


  • Rigid endoscope obturator
COX II Ocular Laser Shield with Suction Cup, 1mm thick, small, 24 x 21mm, each
Hayden Medical, Inc.
OP21-262
In Commercial Distribution

  • 00840319716526 ()
OP21-262

  • Radiation/mechanical corneal shield, reusable
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