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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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Back Brace
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715503294 ()


  • Lumbar spine orthosis
Back Brace
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715503287 ()


  • Lumbar spine orthosis
It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715501597 ()


  • Lumbar spine orthosis
It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715501566 ()


  • Lumbar spine orthosis
New - Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)
PARKELL, INC.
D631ADAPT
Not in Commercial Distribution

  • M595D631ADAPT0 ()
D631ADAPT

  • Dental pulp analysis system
MALLET MEAD1 NEW. REMOVE PLASTICS ENDS OF MALLET WHEN PUTTING INTO AUTOCLAVE.
Power Dental U.S.A. Inc.
4223N
In Commercial Distribution

  • D9434223N00 ()
4223N

  • Surgical mallet
JUELL Cure Hard
PARK DENTAL RESEARCH CORP
JCH-1
Not in Commercial Distribution

  • D769JCH10 ()


  • Denture reliner, hard
IMTEC Cure Hard by JUELL
PARK DENTAL RESEARCH CORP
8720
In Commercial Distribution

  • D76987200 ()


  • Denture reliner, hard
GC Reline ™ Bonding Agent, 12g
Gc America Inc.
346094
In Commercial Distribution

  • 10386040007085 ()
346094

  • Denture reliner, elastic, short-term
GC Reline ™ Intro Package, Standard Package Powder/ Liquid (1 x 80g powder, 1 x 50mL liquid, 1 x 12g Bonding Agent & accessories)
Gc America Inc.
346001
In Commercial Distribution

  • 10386040007078 ()
346001

  • Denture reliner, elastic, short-term
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