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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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Sunglasses
Colors In Optics, Ltd.
NEW DIRECTION ND101 - ROSEGOLD/WHITE
In Commercial Distribution

  • 00781268798709 ()
ND101 RGDWH

  • Tinted non-prescription spectacles
No Description
Light Sources, Inc.
2121
In Commercial Distribution

  • G5102121 ()


  • Ultraviolet tanning device
New Indifferent Plate & Red Cable for Sensimatic® 600SE (Complies with New FDA Lead Wire Regulations)
PARKELL, INC.
D601
In Commercial Distribution

  • 00810000520695 ()
D601

  • Electrosurgical return electrode, reusable
Angel Whole Blood Processing System Machine (NA) New with 15900 NA New Machine Carton Shipping Label
NUO THERAPEUTICS INC
976000100
In Commercial Distribution

  • 00852714003057 ()


  • Apheresis system
New Indifferent Plate & Red Cable for Sensimatic™ 600SE (Complies with New FDA Lead Wire Regulations)
PARKELL, INC.
D601
Not in Commercial Distribution

  • M595D6010 ()
D601

  • Electrosurgical return electrode, reusable
Disposable blood pressure cuff/new style/non-woven fabric/single tube/adult/with BP12-P connector/NEW Partssource
Unimed Medical Supplies, Inc.
U1740S-C12-10
In Commercial Distribution

  • 06945664878401 ()


  • Blood pressure cuff, single-use
S Paste
TOKUYAMA DENTAL CORPORATION
23411
In Commercial Distribution

  • 04548190234110 ()


  • Denture reliner, elastic, long-term
  • Denture reliner, elastic, short-term
S Kit
TOKUYAMA DENTAL CORPORATION
23401
In Commercial Distribution

  • 04548190234011 ()


  • Denture reliner, elastic, short-term
  • Denture reliner, elastic, long-term
HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
Bonago Medical Solutions LLC
REN-HARP-19-60
In Commercial Distribution

  • 00850046400155 ()
  • 20850046400142 ()


  • Composite-polymer suture
No Description
ASSUT EUROPE SPA
FV386M
In Commercial Distribution

  • 38033439004502 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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