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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TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin
Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#
UNIFIED SPINE, LLC
502308
In Commercial Distribution

  • M9935023080 ()

  • Height: 8 Millimeter


  • Orthopaedic bone fixation plate spacer
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-20
In Commercial Distribution

  • 00841365116841 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-4
In Commercial Distribution

  • 00841365116292 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-15
In Commercial Distribution

  • 00841365114991 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=305583#
BEST MEDICAL INTERNATIONAL, INC.
530-12
In Commercial Distribution

  • 00841365114328 ()


  • General-purpose brachytherapy system applicator, manual
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable
UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens
COPAN ITALIA SPA
3C030N.HL
In Commercial Distribution

  • 58053326009117 ()
  • 38053326009113 ()
  • 08053326009112 ()
3C030N.HL

  • General specimen container IVD, additive/medium
UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
COPAN ITALIA SPA
330C.HL
In Commercial Distribution

  • 58053326008974 ()
  • 38053326008970 ()
  • 08053326008979 ()
330C.HL

  • General specimen container IVD, additive/medium
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#
SPES MEDICA SPA
TFDN452501
In Commercial Distribution

  • 18054655015154 ()
  • 08054655015157 ()


  • Electromyographic needle electrode, single-use
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software
Micro Injection Needle Style II 11ga x 9cm Luer Lockhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Ebner Medical, LLC
AA7771109
In Commercial Distribution

  • 00840217906166 ()

  • Length: 9 Centimeter
  • Outer Diameter: 3.048 Millimeter


  • Surgical/emergency suction cannula, non-illuminating, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22141
Not in Commercial Distribution

  • 00814356021516 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22140
Not in Commercial Distribution

  • 00814356021509 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22139
Not in Commercial Distribution

  • 00814356021493 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22138
Not in Commercial Distribution

  • 00814356021486 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22137
Not in Commercial Distribution

  • 00814356021479 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22136
Not in Commercial Distribution

  • 00814356021462 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22135
Not in Commercial Distribution

  • 00814356021455 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22134
Not in Commercial Distribution

  • 00814356021448 ()


  • Dental appliance fabrication material, ceramic
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