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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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The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3540LS
In Commercial Distribution

  • M269PSS3540LS1 ()
  • 10381780121183 ()

  • 1.683 in L x .138 in dia
PSS3540LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3535LS
In Commercial Distribution

  • M269PSS3535LS1 ()
  • 10381780121169 ()

  • 1.486 in L x .138 in dia
PSS3535LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3530LS
In Commercial Distribution

  • M269PSS3530LS1 ()
  • 10381780121145 ()

  • 1.289 in L x .138 in dia
PSS3530LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232054
In Commercial Distribution

  • ESDG2320541 ()


  • Dental composite resin
Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use
Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0704610
In Commercial Distribution

  • 10888234001775 ()
0704610

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MP8-W
In Commercial Distribution

  • B140MP8W0 ()
MP8-W

  • Polysomnograph
The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422540
In Commercial Distribution

  • B413AW4225400 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use
The Etchmaster system is intended for use is for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Tip, Large
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRL
In Commercial Distribution

  • D798EMTRL1 ()
  • D798EMTRL0 ()
EMTRL

  • Dental abrasive air jet system
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