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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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RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency
Wide Handle Utrata 0.12
MICROSURGICAL TECHNOLOGY, INC.
AF0290 AI
In Commercial Distribution

  • 00844685009480 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
DENJOY DENTAL CO.,LTD
Ai Mate-II
In Commercial Distribution

  • 06970873260259 ()


  • Multi-purpose surgical power tool system, line-powered
No Description
DENJOY DENTAL CO.,LTD
Ai Mate-I
In Commercial Distribution

  • 06970873260198 ()


  • Multi-purpose surgical power tool system, line-powered
HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
Scale, Digital Home Health Model DHH-10BT 440lb (200kg) x0.2lb (0.1kg) 300mm (L) x 360mm (W) x 8mm (H) includes (2) AAA batteries, tempered glass Includes Bluetooth connectivity compatible with Apple Health and Google Health APP
Rice Lake Weighing Systems, Inc.
DHH-10BT
In Commercial Distribution

  • 00850042373255 ()
201125

  • Stand-on floor scale, electronic
Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.
SECONDPERSPECTIVE LTD.
V2MDR-01
In Commercial Distribution

  • 05070000320403 ()


  • Tourniquet cuff, reusable
TPH®3 Easy-Twist Syringe Introductory Kit
DENTSPLY INTERNATIONAL INC.
642706
Not in Commercial Distribution

  • D0026427061 ()

  • Weight: 3 Gram
  • Total Volume: 3 Milliliter
  • 8 TPH3 Syringes, 5 P&B Unit Doses, 1 Prisma Gloss Fine and Extrafine Syringe, 1 syringe Tooth Cond Gel, 1 shade guide, 25 polishing cups, 1 mandrel, Enhance Discs, Cups, & Points, 5 App Tips
642706

  • Dental composite resin
Safety Hypodermic Needle 27G×1/2"
Shanghai Kindly Enterprise Development Group Co.,Ltd.
SENG-2713R
In Commercial Distribution

  • 16930197851899 ()
  • 06930197851892 ()
  • 26930197851896 ()


  • Hypodermic needle, single-use
Disposable Syringe without Needle 1cc/ml
Shanghai Kindly Enterprise Development Group Co.,Ltd.
SENG - SS-01L
In Commercial Distribution

  • 16930197851912 ()
  • 06930197851915 ()
  • 26930197851919 ()


  • General-purpose syringe/needle
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