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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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Rexton - 05714880155693

HA BICORE R-LI T 20 DBR
Ws Audiology Usa, Inc.
BiCore R-Li T 20
In Commercial Distribution

  • 05714880155693 ()
21013165

  • Air-conduction hearing aid, receiver-in-canal

Rexton - 05714880155686

HA BICORE R-LI T 20 BLK
Ws Audiology Usa, Inc.
BiCore R-Li T 20
In Commercial Distribution

  • 05714880155686 ()
21013171

  • Air-conduction hearing aid, receiver-in-canal

Rexton - 05714880155679

HA BICORE R-LI T 20 BG
Ws Audiology Usa, Inc.
BiCore R-Li T 20
In Commercial Distribution

  • 05714880155679 ()
21013162

  • Air-conduction hearing aid, receiver-in-canal

SPOTCHECK - 00725609000137

Biotinidase Microplate Reagent Kit, 20 Plate
ASTORIA-PACIFIC, INC.
81-8000-13K
In Commercial Distribution

  • 00725609000137 ()
81-8000-13K

  • Biotinidase IVD, kit, spectrophotometry

SPOTCHECK - 00725609000113

GALT Microplate Reagent Kit, 20 Plate
ASTORIA-PACIFIC, INC.
81-4000-20K
In Commercial Distribution

  • 00725609000113 ()
81-4000-20K

  • Galactose-1-phosphate uridyl transferase IVD, kit, spectrophotometry

Malibu - 10889981008468

UNI-PLANAR DLTA SCREW,4.5 X 20
Seaspine Orthopedics Corporation
69-4520
Not in Commercial Distribution

  • 10889981008468 ()

  • 4.5 X 20
69-4520

  • Bone-screw internal spinal fixation system, non-sterile

NiBP, Disposable, Small Adult, 20 - 28cm - 00884838034303

NiBP, Disp, Small Adult, 20 - 28cm
Philips Ds North America LLC
Cuff, NIBP, Disp, Small Adult, 20-28cm
Not in Commercial Distribution

  • 00884838034303 ()
989803170451

  • Blood pressure cuff, reusable

Rampart One Lumbar Interbody Fusion System - M7404902033

Rampart One Trial, 18mm, M, 20°
SPINEOLOGY INC.
49-02-01-33
In Commercial Distribution

  • M7404902033 ()

  • 20° Lordosis
  • Medium Footprint
  • Height: 18 Millimeter
490-2033

  • Polymeric spinal fusion cage, sterile

Rampart One Lumbar Interbody Fusion System - M7404902031

Rampart One Trial, 16mm, M, 20°
SPINEOLOGY INC.
49-02-01-31
In Commercial Distribution

  • M7404902031 ()

  • Height: 16 Millimeter
  • Medium Footprint
  • 20° Lordosis
490-2031

  • Polymeric spinal fusion cage, sterile

RECLAIM - 10603295553922

RECLAIM MONOBLOC DISTAL REAMER SHORT 20
DEPUY (IRELAND)
34-165-0020
In Commercial Distribution

  • 10603295553922 ()
341650020

  • Bone-resection orthopaedic reamer, reusable
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