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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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2.7mm 12 Degree Cystoscope, Autoclave, High Performance German Optics, Slim Line ACMI Fit (New Long
Surgical Direct, Inc.
SD827-126SL
In Commercial Distribution

  • B382SD827126SL0 ()
SD827-126SL

  • Rigid optical cystoscope
3M™ ESPE™ Lava™ Ultimate Restorative New User Kit for TS150™, 2614TN
3M COMPANY
2614TN
Not in Commercial Distribution

  • 30605861051218 ()
2614TN

  • Resin dental inlay
3M™ ESPE™ Lava™ Ultimate Restorative New User Kit for E4D®, 3114EN
3M COMPANY
3114EN
Not in Commercial Distribution

  • 30605861048119 ()
3114EN

  • Resin dental inlay
Disposable blood pressure cuff/new style/non-woven fabric/single tube/adult/with BP12-P connector/MAC
Unimed Medical Supplies, Inc.
U1M740S-C12
In Commercial Distribution

  • 06945664878418 ()


  • Blood pressure cuff, single-use
Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
No Description
Suzhou Colourway New Material Co., Ltd.
Large size Condoms, medium (55 ± 2mm) thickness: 0.06 ± 0.01mm
In Commercial Distribution

  • 06925634004511 ()


  • Basic male condom, Hevea-latex
No Description
Suzhou Colourway New Material Co., Ltd.
Extra Dotted Condoms, medium (53 ± 2mm) thickness: 0.06 ± 0.01mm
In Commercial Distribution

  • 06925634004504 ()


  • Basic male condom, Hevea-latex
No Description
Suzhou Colourway New Material Co., Ltd.
Active ribbed Male Latex Condoms, medium (53 ± 2mm) thickness: 0.065 ± 0.015mm
In Commercial Distribution

  • 06925634004092 ()


  • Basic male condom, Hevea-latex
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