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 Class Implantable

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SBN Locking Bushing Step Drill
Acumed LLC
80-2472
In Commercial Distribution

  • 10806378097829 ()


  • General internal orthopaedic fixation system implantation kit
Broad Needle, Hex Key Adaptor (1 pc)
SONIQUENCE, LLC
SBN
In Commercial Distribution

  • 00810026180958 ()
  • 00810026181009 ()
SBN

  • Open-surgery electrosurgical electrode, monopolar, single-use
Bonelevel - Narrow platform - Connection: NC (Ø3,0)
3shape Trios A/S
SBN
In Commercial Distribution

  • 05902729752084 ()

  • Outer Diameter: 3.0 Millimeter


  • Dental milling system, CAD/CAM, laboratory
Monoblock 3,00 driver
ODONTIT S.A.
SBN
In Commercial Distribution

  • D914SBN0 ()
SBN

  • Screw endosteal dental implant, two-piece
SBN Push Button ESU Pencil - 2.5'' Stainless Blade, Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
SBH Push Button ESU Pencil
In Commercial Distribution

  • 20817325020897 ()
  • 10817325020890 ()
  • 00817325020893 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SBN Push Button ESU Pencil - 2.5'' Stainless & Coated Blade, No Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
SBN Push Button ESU Pencil
In Commercial Distribution

  • 20817325020873 ()
  • 10817325020876 ()
  • 00817325020879 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
4019-100
In Commercial Distribution

  • 00848665032055 ()


  • Medullary canal orthopaedic reamer, rigid
Assortment Pack (24pcs) Hex Key Adaptor (includes 3 each:Fine Wire (SST-W), Ball (SST-B3), Spatula (SST-S), Small loop (SST-L5), Large loop (SST-L10), Broad Needle (SBN), Pin (SPIN), Multi-Glide (SVT))
SONIQUENCE, LLC
SASST-24
In Commercial Distribution

  • 00810026180897 ()
SASST-24

  • Open-surgery electrosurgical electrode, monopolar, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
SBN, Straumann - Bonelevel NC Ø3.3
In Commercial Distribution

  • 05744003810628 ()
80610249

  • Dental implant abutment analog, scanning
The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).
HAN CHANG CO., LTD
SpineKure Kyphoplasty System
In Commercial Distribution

  • 08809300542973 ()


  • Balloon kyphoplasty kit
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