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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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Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Bag of 50 Pieces Bulk Packaged
ANESTHESIA ASSOCIATES, INC.
E-126-050
In Commercial Distribution

  • B005E1260500 ()
  • B005E1260506 ()
E-126-050

  • Intubation teeth protector
Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Package of 10 Individually Bagged Units
ANESTHESIA ASSOCIATES, INC.
E-126-010
In Commercial Distribution

  • B005E1260100 ()
  • B005E1260103 ()
E-126-010

  • Intubation teeth protector
Distal Radio-Ulnar Joint Stem, Standard, 5.0 mm Diameter. THIS ITEM IS NO LONGER IN DISTRIBUTION.
APTIS MEDICAL, LLC
DRUJ-IS050
Not in Commercial Distribution

  • B013DRUJIS0500 ()
DRUJ-IS050

  • Wrist ulna-head prosthesis
Distal Radio-Ulnar Joint Stem, Standard, 4.5 mm Diameter. THIS ITEM IS NO LONGER IN DISTRIBUTION.
APTIS MEDICAL, LLC
DRUJ-IS045
Not in Commercial Distribution

  • B013DRUJIS0450 ()
DRUJ-IS045

  • Wrist ulna-head prosthesis
SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350201490 ()
502-0149

  • Electroencephalograph
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350101320 ()
502-0132

  • Electroencephalograph
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Steel
Shoulder Innovations, Inc.
33 mm x 10°
In Commercial Distribution

  • B1132N1AI330100 ()
2N1AI33010

  • Total shoulder prosthesis
  • Shoulder glenoid fossa prosthesis, prefabricated
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 5°, Stainless Steel
Shoulder Innovations, Inc.
33 mm x 5°
In Commercial Distribution

  • B1132N1AI330050 ()
2N1AI33005

  • Shoulder glenoid fossa prosthesis, prefabricated
  • Total shoulder prosthesis
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 30mm x 10°, Stainless Steel
Shoulder Innovations, Inc.
30 mm x 10°
In Commercial Distribution

  • B1132N1AI300100 ()
2N1AI30010

  • Total shoulder prosthesis
  • Shoulder glenoid fossa prosthesis, prefabricated
Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 30mm x 5°, Stainless Steel
Shoulder Innovations, Inc.
30 mm x 5°
In Commercial Distribution

  • B1132N1AI300050 ()
2N1AI30005

  • Shoulder glenoid fossa prosthesis, prefabricated
  • Total shoulder prosthesis
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