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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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ONE® Premium Pleasures North America 24-Pack
GLOBAL PROTECTION CORP.
11824
In Commercial Distribution

  • 80726893110867 ()
  • 00726893110861 ()
  • 10726893110868 ()


  • Basic male condom, Hevea-latex
DRILL 3.5 AMP STERILE - BOX OF ONE
Smith & Nephew, Inc.
72202820
In Commercial Distribution

  • 00885554000399 ()
72202820

  • Cannulated surgical drill bit, single-use
Inogen One G4 Oxygen Concentrator - Bluetooth (10-08300-00-01)
Inogen, Inc.
630 Bluetooth
In Commercial Distribution

  • 00817131020179 ()
IO-400

  • Mobile/portable oxygen concentrator
Inogen One G5 Oxygen Concentrator - Bluetooth (10-08123-XX-XX)
Inogen, Inc.
1260 Bluetooth
In Commercial Distribution

  • 00817131020162 ()
IO-500

  • Mobile/portable oxygen concentrator
ONE PIECE DUAL OFFSET RIGHT BROACH HANDLE
Smith & Nephew, Inc.
E0014946-2
Not in Commercial Distribution

  • 00885556645703 ()
E0014946-2

  • Surgical instrument handle, non-torque-limiting
ONE PIECE DUAL OFFSET LEFT BROACH HANDLE
Smith & Nephew, Inc.
E0014946-1
Not in Commercial Distribution

  • 00885556645697 ()
E0014946-1

  • Surgical instrument handle, non-torque-limiting
MicroMega One RECI Guttapercha Points 0.0~ #45
Coltène/Whaledent GmbH + Co. KG
60037026
In Commercial Distribution

  • 04260614073432 ()
  • 14260614073439 ()
60037026

  • Root canal obturating point
One Piece™ Implant Ratchet Driver Short
INTRA-LOCK INTERNATIONAL, INC.
OPRDS
In Commercial Distribution

  • D742OPRDS0 ()
OPRDS

  • Surgical screwdriver, reusable
Initial IQ ONE,SQIN System SET, 228g
Gc America Inc.
877098
In Commercial Distribution

  • J0228770981 ()
877098

  • Dental appliance fabrication material, ceramic
Initial IQ,LP ONE,V-Shades Set, 88g
Gc America Inc.
877096
In Commercial Distribution

  • J0228770961 ()
877096

  • Dental appliance fabrication material, ceramic
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