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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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LinkStation MINI with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020457 ()
05000-002

  • Arthroplasty force sensor display unit
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022145 ()
EVA151C:

  • Dental implant system
Syringe Irrigation Piston Flat Top with New Cath Tip
MCKESSON MEDICAL-SURGICAL INC.
911
In Commercial Distribution

  • 40612479201932 ()
  • 10612479201924 ()


  • ENFit oral/enteral syringe, single-use
Personal Use Kit OC-Auto, for Trinity Health New England
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-THNE
In Commercial Distribution

  • 00816917027128 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Yale New Haven Medical
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-YNHM
In Commercial Distribution

  • 00816917024547 ()


  • Faecal occult blood IVD, reagent
new version of Mesa Labs pHoenix XL Dialysate Meter
MESA LABORATORIES, INC.
36-00001
In Commercial Distribution

  • M98536000010 ()
36-00300

  • Multi-parameter device tester
D615 NM GANTRY 3_8 WITH NEW ROTOR TOP - MEA
GE Hualun Medical Systems Co., Ltd
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system
B615 to D630 upgrade kits option with new ROTOR
GE Hualun Medical Systems Co., Ltd
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system
NUBERT Plus New Bag for Endoscopic Retrieval of Tissue
VERNACARE LIMITED
24004
In Commercial Distribution

  • 05019829240042 ()
  • 05019829239954 ()

  • Total Volume: 100 Milliliter
24004

  • Tissue extraction bag
Natus Elite v2 Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
688-630200
In Commercial Distribution

  • 00382830062251 ()


  • Electromyograph
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