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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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COLPAC FREEZER, C/W 12 STD. CO LPACS US STD
DJO, LLC
90910
In Commercial Distribution

  • 00888912042970 ()


  • Cold therapy pack chilling unit
COVER BACK TABLE_50"X 90"_SMS_non-sterile_300EA/CS
GRI Medical & Electronic Technology Co., Ltd.
8065-1538-99-Sample
In Commercial Distribution

  • 06931918115514 ()
  • 16931918115511 ()


  • Patient surgical drape, single-use
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Screw T6 Torx 2mm X 5mm Model Number 241-04B Screw T6 Torx 2mm X 6mm Model Number 241-04C
Neurovention LLC
241-04
In Commercial Distribution

  • G28424104 ()


  • Craniofacial bone screw, non-bioabsorbable
FIZE kUO Disposable Kit Catalog number for 1 pc: FI-KT00-KU01-0001 Catalog number for 10 pcs in box: FI-FG00-KU03-0001
FIZE RESEARCH LTD
G1
In Commercial Distribution

  • 17290019239243 ()
  • 07290019239246 ()
  • 07290019239093 ()
FI-KT00-KU01-0001

  • Urine monitoring system
Orion Trial Neck, High Offset, Size 8-9 (Version or Model Number) Has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122208
In Commercial Distribution

  • M716101222080 ()
101-222-6252

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 2-3 (Version or Model Number) has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122202
In Commercial Distribution

  • M716101222020 ()
111-19-6262

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 0-1 (Version or Model Number) Has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122200
In Commercial Distribution

  • M716101222000 ()
111-19-6261

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 10-12 (Version or Model Number) has been changed to the Catalog number.
ORTHOMEDFLEX LLC
10122110
In Commercial Distribution

  • M716101221100 ()
111-19-6256

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 8-9 (Version or Model Number) has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122108
In Commercial Distribution

  • M716101221080 ()
111-19-6255

  • Femoral stem prosthesis trial
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