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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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One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-140
In Commercial Distribution

  • 20353885006839 ()
  • 00353885006835 ()
  • 53885-140-20 ()
  • 80353885006831 ()

  • Needle Gauge: 28 Gauge


  • Manual blood lancing device, single-use
One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-139
In Commercial Distribution

  • 53885-139-20 ()
  • 00353885006828 ()
  • 80353885006824 ()
  • 20353885006822 ()

  • Needle Gauge: 21 Gauge


  • Manual blood lancing device, single-use
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 10F; length 110cm), one Aspirex™ Guidewire (0.025” diameter; 270cm in length), one collecting bag, and one sterile drape.
Straub Medical AG
80328
In Commercial Distribution

  • 07640142811350 ()

  • Catheter Gauge: 10 French
  • Catheter Working Length: 110 Centimeter
80328

  • Thrombectomy rotational catheter
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 8F; length 110cm), one Aspirex™ Guidewire (0.018” diameter; 270cm in length), one collecting bag, and one sterile drape.
Straub Medical AG
80327
In Commercial Distribution

  • 07640142811343 ()

  • Catheter Gauge: 8 French
  • Catheter Working Length: 110 Centimeter
80327

  • Thrombectomy rotational catheter
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 8F; length 85cm), one Aspirex™ Guidewire (0.018” diameter; 220cm in length), one collecting bag, and one sterile drape.
Straub Medical AG
80326
In Commercial Distribution

  • 07640142811336 ()

  • Catheter Gauge: 8 French
  • Catheter Working Length: 85 Centimeter
80326

  • Thrombectomy rotational catheter
Contains one (1) PermaSoft® Combination Kit (N811500) and one (1) PermaSoft® Trial Kit (N811400)
Dentsply International Inc.
Promotional Pack
Not in Commercial Distribution

  • D001N8116000 ()
N811600

  • Dental appliance fabrication material, resin
OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit
Reshape Lifesciences Inc.
9600-0001
Not in Commercial Distribution

  • 00859810006074 ()
  • 10859810006071 ()


  • Appetite-suppression gastric balloon
4 3/4 inch Wire Cutting Scissor Angled to one Side, One Serrated Blade, TC Insert
Surgical Direct, Inc.
SD90398712
In Commercial Distribution

  • B382SD903987120 ()
SD90398712

  • General-purpose surgical scissors, single-use
Integra® Miltex® Putti Bone Rasp 12-1/4", Double-Ended, Curved Blades, One Round/One Half-Round
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH27-702
In Commercial Distribution

  • H834MH277020 ()
  • 10381780451280 ()
MH27-702

  • Bone file/rasp, manual, reusable
Integra® Miltex® Putti Bone Rasp, 10-1/2", Double-Ended, One Curved Up, One Curved Sideways
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH27-700
In Commercial Distribution

  • H834MH277000 ()
  • 10381780445685 ()

  • 10-1/2"
MH27-700

  • Bone file/rasp, manual, reusable
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