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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Silicone Gel Sizer, Smooth Round, Moderate Projection, 150 cc
Sientra, Inc.
GS10712-150MP
In Commercial Distribution

  • 00810076890340 ()

  • Volume:150 cc
GS10712-150MP

  • Invasive breast implant sizer, fixed, single-use
Silicone Gel Sizer, Smooth Round, Moderate Projection, 120 cc
Sientra, Inc.
GS10712-120MP
In Commercial Distribution

  • 00810076890333 ()

  • Volume:120 cc
GS10712-120MP

  • Invasive breast implant sizer, fixed, single-use
Silicone Gel Sizer, Smooth Round, Moderate Projection, 100 cc
Sientra, Inc.
GS10712-100MP
In Commercial Distribution

  • 00810076890326 ()

  • Volume:100 cc
GS10712-100MP

  • Invasive breast implant sizer, fixed, single-use
Silicone Gel Sizer, Smooth Round, Moderate Projection, 80 cc
Sientra, Inc.
GS10712-080MP
In Commercial Distribution

  • 00810076890319 ()

  • Volume:080 cc
GS10712-080MP

  • Invasive breast implant sizer, fixed, single-use
Joint finder
OMNIA MEDICAL, LLC
11-5P-JFR1
In Commercial Distribution

  • 00843511121228 ()
11-5P-JFR1

  • Orthopaedic chisel
The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.
Ulab Systems, Inc.
FG0010
In Commercial Distribution

  • 00860461001790 ()


  • Orthodontic progressive aligner
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89040PPT
In Commercial Distribution

  • M269TRL89040PPT1 ()
  • 10381780236955 ()

  • Size 40; .771 in L x .549 in W (head); .472 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPT
In Commercial Distribution

  • M269TRL89030PPT1 ()
  • 10381780236924 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89020PPT
In Commercial Distribution

  • M269TRL89020PPT1 ()
  • 10381780236894 ()

  • Size 20; .66 in L x .493 in W (head); .394 in L (stem)


  • Surgical implant template, reusable
The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89010PPT
In Commercial Distribution

  • M269TRL89010PPT1 ()
  • 10381780236863 ()

  • Size 10; .606 in L x .463 in W (head); .354 in L (stem)


  • Surgical implant template, reusable
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