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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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Disposable Prophy Angles
Premium Plus International Limited
B-CTS3399-60SA
In Commercial Distribution

  • D838BCTS339960SA2 ()
  • D838BCTS339960SA0 ()
  • D838BCTS339960SA8 ()


  • Dental polishing cup, single-use
Disposable Prophy Angles
Premium Plus International Limited
B-CTS3399-60RD
In Commercial Distribution

  • D838BCTS339960RD2 ()
  • D838BCTS339960RD0 ()
  • D838BCTS339960RD8 ()


  • Dental polishing cup, single-use
Disposable Prophy Angles
Premium Plus International Limited
B-CTS3399-60RA
In Commercial Distribution

  • D838BCTS339960RA2 ()
  • D838BCTS339960RA0 ()
  • D838BCTS339960RA8 ()


  • Dental polishing cup, single-use
SmartArch .016" (0.406mm) Round Damon Upper Orthodontic CuNiTi Archwire
Smarter Alloys Inc
SAO-DROU-0016
In Commercial Distribution

  • D948SAODROU00160 ()
  • D948SAODROU00161 ()


  • Orthodontic archwire
SmartArch .016" (0.406mm) Round Damon Lower Orthodontic CuNiTi Archwire
Smarter Alloys Inc
SAO-DROL-0016
In Commercial Distribution

  • D948SAODROL00161 ()
  • D948SAODROL00160 ()


  • Orthodontic archwire
SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Upper Orthodontic CuNiTi Archwire
Smarter Alloys Inc
SAO-DREU-1825
In Commercial Distribution

  • D948SAODREU18251 ()
  • D948SAODREU18250 ()


  • Orthodontic archwire
SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Lower Orthodontic CuNiTi Archwire
Smarter Alloys Inc
SAO-DREL-1825
In Commercial Distribution

  • D948SAODREL18251 ()
  • D948SAODREL18250 ()


  • Orthodontic archwire
No Description
DELTA HI TECH INC
744
In Commercial Distribution

  • DHT17442 ()
  • DHT17441 ()
  • DHT17440 ()


  • Insulin syringe/needle, basic
No Description
DELTA HI TECH INC
742
In Commercial Distribution

  • DHT17422 ()
  • DHT17421 ()
  • DHT17420 ()


  • Insulin syringe/needle, basic
No Description
DELTA HI TECH INC
740
In Commercial Distribution

  • DHT17402 ()
  • DHT17401 ()
  • DHT17400 ()


  • Insulin syringe/needle, basic
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