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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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ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLB
In Commercial Distribution

  • 50195594959188 ()
  • 10195594959180 ()
SBA11LLSLB

  • Laparoscopic surgical procedure kit, non-medicated, single-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL4
In Commercial Distribution

  • 50195594797131 ()
  • 10195594797133 ()
SBA11LLSL4

  • Laparoscopic surgical procedure kit, non-medicated, single-use
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
Reference strain
Ssi Diagnostica A/S
85340
In Commercial Distribution

  • 05713106853405 ()
85340

  • Escherichia coli antigen IVD, control
PERIODONTAL SCALER DOUBLE ENDED TOWNER /JACQUETTE, H5/33, HOLLOW HANDLE
Helmut Zepf Medizintechnik GmbH
24.565.33
In Commercial Distribution

  • EZPF24565330 ()
24.565.33

  • Periodontal curette
30GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.5.00 MM
SWEDEN & MARTINA SPA
A-PAD-AA500-305
In Commercial Distribution

  • D7700871873 ()
A-PAD-AA500-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.5.00 MM
SWEDEN & MARTINA SPA
A-PAD-AA500-175
In Commercial Distribution

  • D7700871853 ()
A-PAD-AA500-175

  • Dental implant suprastructure, permanent, preformed
30GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.4.25 MM
SWEDEN & MARTINA SPA
A-PAD-AA425-305
In Commercial Distribution

  • D7700871833 ()
A-PAD-AA425-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.4.25 MM
SWEDEN & MARTINA SPA
A-PAD-AA425-175
In Commercial Distribution

  • D7700871813 ()
A-PAD-AA425-175

  • Dental implant suprastructure, permanent, preformed
30GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.3.80 MM
SWEDEN & MARTINA SPA
A-PAD-AA380-305
In Commercial Distribution

  • D7700871793 ()
A-PAD-AA380-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM-KOHNO D.3.80 MM
SWEDEN & MARTINA SPA
A-PAD-AA380-175
In Commercial Distribution

  • D7700871773 ()
A-PAD-AA380-175

  • Dental implant suprastructure, permanent, preformed
30GR ANGLED PAD ABUT., H5 MM PREMIUM D.3.30 MM
SWEDEN & MARTINA SPA
A-PAD-AA330-305
In Commercial Distribution

  • D7700871753 ()
A-PAD-AA330-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM PREMIUM D.3.30 MM
SWEDEN & MARTINA SPA
A-PAD-AA330-175
In Commercial Distribution

  • D7700871733 ()
A-PAD-AA330-175

  • Dental implant suprastructure, permanent, preformed
Integra® Miltex® Scaler H5/33, Double-Ended, Octagonal Handle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
70-124
In Commercial Distribution

  • 10381780450245 ()
  • H8347001240 ()
70-124

  • Manual dental scaler, reusable
30GR ANG. EST. PAD ABUT. H5 MM, D.5.00 MM
SWEDEN & MARTINA SPA
AS-PADE-AA500-305
In Commercial Distribution

  • D7702680403 ()
AS-PADE-AA500-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. EST. PAD ABUT. H5 MM, D.5.00 MM
SWEDEN & MARTINA SPA
AS-PADE-AA500-175
In Commercial Distribution

  • D7702680383 ()
AS-PADE-AA500-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. EST. PAD ABUT. H5 MM, D.4.25 MM
SWEDEN & MARTINA SPA
AS-PADE-AA425-305
In Commercial Distribution

  • D7702680363 ()
AS-PADE-AA425-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. EST. PAD ABUT. H5 MM, D.4.25 MM
SWEDEN & MARTINA SPA
AS-PADE-AA425-175
In Commercial Distribution

  • D7702680343 ()
AS-PADE-AA425-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. EST. PAD ABUT. H5 MM, D.3.80 MM
SWEDEN & MARTINA SPA
A-PADE-AA380-305
In Commercial Distribution

  • D7702680243 ()
A-PADE-AA380-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. EST. PAD ABUT. H5 MM, D.3.80 MM
SWEDEN & MARTINA SPA
A-PADE-AA380-175
In Commercial Distribution

  • D7702680223 ()
A-PADE-AA380-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. EST. PAD ABUT. H5 MM, D.3.30 MM
SWEDEN & MARTINA SPA
A-PADE-AA330-305
In Commercial Distribution

  • D7702680183 ()
A-PADE-AA330-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. EST. PAD ABUT. H5 MM, D.3.30 MM
SWEDEN & MARTINA SPA
A-PADE-AA330-175
In Commercial Distribution

  • D7702680163 ()
A-PADE-AA330-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. RED. PAD ABUT. H5 MM, D.5.00 MM
SWEDEN & MARTINA SPA
AS-PADR-AA500-305
In Commercial Distribution

  • D7701585853 ()
AS-PADR-AA500-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. RED. PAD ABUT. H5 MM, D.5.00 MM
SWEDEN & MARTINA SPA
AS-PADR-AA500-175
In Commercial Distribution

  • D7701585833 ()
AS-PADR-AA500-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. RED. PAD ABUT. H5 MM, D.4.25 MM
SWEDEN & MARTINA SPA
AS-PADR-AA425-305
In Commercial Distribution

  • D7701585813 ()
AS-PADR-AA425-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. RED. PAD ABUT. H5 MM, D.4.25 MM
SWEDEN & MARTINA SPA
AS-PADR-AA425-175
In Commercial Distribution

  • D7701585793 ()
AS-PADR-AA425-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. RED. PAD ABUT. H5 MM, D.3.80 MM
SWEDEN & MARTINA SPA
A-PADR-AA380-305
In Commercial Distribution

  • D7701585773 ()
A-PADR-AA380-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. RED. PAD ABUT. H5 MM, D.3.80 MM
SWEDEN & MARTINA SPA
A-PADR-AA380-175
In Commercial Distribution

  • D7701585753 ()
A-PADR-AA380-175

  • Dental implant suprastructure, permanent, preformed
30GR ANG. RED. PAD ABUT. H5 MM, D.3.30 MM
SWEDEN & MARTINA SPA
A-PADR-AA330-305
In Commercial Distribution

  • D7701585733 ()
A-PADR-AA330-305

  • Dental implant suprastructure, permanent, preformed
17GR ANG. RED. PAD ABUT. H5 MM, D.3.30 MM
SWEDEN & MARTINA SPA
A-PADR-AA330-175
In Commercial Distribution

  • D7701585713 ()
A-PADR-AA330-175

  • Dental implant suprastructure, permanent, preformed
Pediatric- Preformed zirconia crown Upper Canine size C/H5 (UC5)
KIDS-E-DENTAL LLP
C/H5 (UC5)
In Commercial Distribution

  • 08906154840214 ()


  • Preformed dental crown, temporary
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring
CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring
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