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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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XT Sense with Humidifier
Wellell Inc.
9S-005530, 9S-006500
In Commercial Distribution

  • 14713025000049 ()
  • 04713025000042 ()


  • Home CPAP unit
  • Heated respiratory humidifier
XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • Home CPAP unit
  • Heated respiratory humidifier
Weichel Scissors with Guide
SCANLAN INTERNATIONAL INC
1-8483
In Commercial Distribution

  • 00846159031324 ()
1-8483

  • General-purpose surgical scissors, reusable
with ratchet curved jaw
SCANLAN INTERNATIONAL INC
6006-176
In Commercial Distribution

  • 00846159020496 ()
6006-176

  • Suturing needle holder, reusable
CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CREC4
In Commercial Distribution

  • 50888439463833 ()
  • 10888439463835 ()
SNE69CREC4

  • Craniotomy kit
with ratchet curved jaw
SCANLAN INTERNATIONAL INC
6006-172
In Commercial Distribution

  • 00846159023282 ()
6006-172

  • Suturing needle holder, reusable
KNEE WITH ACL RECONSTRUCTION
Cardinal Health 200, LLC
SOP34ARKS1
In Commercial Distribution

  • 50888439523971 ()
  • 10888439523973 ()
SOP34ARKS1

  • Orthopaedic surgical procedure kit, non-medicated, single-use
CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASC
In Commercial Distribution

  • 50888439529836 ()
  • 10888439529838 ()
SEY44CAASC

  • Ophthalmic surgical procedure kit, medicated, single-use
KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS440132B
In Commercial Distribution

  • 50888439513330 ()
  • 10888439513332 ()
OMS440132B

  • General surgical procedure kit, non-medicated, single-use
Precision System with Needle
STRYKER CORPORATION
0506485000
Not in Commercial Distribution

  • 34546540907036 ()
  • 04546540907035 ()

  • Needle Gauge: 13.0 Gauge
0506-485-000

  • Orthopaedic cement preparation/delivery kit
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