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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Ti Screw Ø 3,5
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566620690 ()
IPD/OB-TN-00

  • Dental prosthesis/implant abutment screw
Temporary abutment Non-Engaging Ø 4,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566620621 ()
IPD/OB-PR-07

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary abutment Engaging Ø 4,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566620614 ()
IPD/OB-PR-06

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary abutment Non-Engaging Ø 3,5
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566620607 ()
IPD/OB-PN-07

  • Dental implant suprastructure, temporary, preformed, single-use
Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent
Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Screw For MUA 1.4 (Blue) - Elemental Ref: EZA14
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566643002 ()
IPD/AB-TR-01

  • Dental prosthesis/implant abutment screw
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