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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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The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK15 ()
OS3CDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
Lap Port Closure Device Kit with10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK15
In Commercial Distribution

  • B354OSLPCDK15 ()
OSLPCDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
It is a Wi-Fi camera with type C connection that allows the digitization of images taken on Tablets, smartphones and PCs using dedicated Apps and Software. It is compatible with most optical devices such as microscopes, endoscopes and fiberoptic endoscopes, lenses with C-mount type attachment in addition to the appropriate Couplers or adapters supplied.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-309
Not in Commercial Distribution

  • B1621111 ()


  • Otoscope, direct
No-Scratch ™ Large Whitney Curette ™ is a single-use, plastic curette for quickly applying, manipulating and removing bone cement during hip and knee replacement surgery. The plastic is softer than steel instruments, reducing the risk of damaging the prosthesis with metal instruments. The large curette’s 20mm tip removes excess cement from replacement hips and knees. Easy-to-maneuver, the large yellow curette lets you remove cement from all edges of the prosthesis. No-Scratch Large Whitney Curette Features: SAFER THAN STEEL - Made of plastic - sturdy yet softer than surgical steel. HANDIER - Each tool has a molded-in thumb indentation instantly orienting the tool. - Easier to maneuver in hard to see places. - Color-coded for easy identification. FASTER - Comes individually packaged in sterile, peel open pouch, ready to go. - Applies, manipulates, or removes cement with fingertip precision. ECONOMICAL - The cost of a single revision dwarfs the cost of a single-use curette. - Disposable – there’s no need to waste time removing hardened cement or re-sterilizing tools. - Less expensive to buy and inventory - order only the tool you use. - Packaged 25 individually wrapped tools to a carton for convenient shelf storage.
Whitney Medical Solutions
OR1202
In Commercial Distribution

  • M266OR12021 ()
  • M266OR12020 ()

  • Width: 12 Millimeter
  • Length: 20 Millimeter
OR1202

  • Orthopaedic cement curette
No-Scratch ™ Small Whitney Curette ™ is a single-use, plastic curette for quickly applying, manipulating and removing bone cement during hip and knee replacement surgery. The plastic is softer than steel instruments, reducing the risk of damaging the prosthesis with metal instruments. The curette’s 6mm tip removes excess cement from replacement hips and knees. Easy-to-maneuver, the small blue curette lets you remove cement from all edges of the prosthesis. No-Scratch Whitney Small Curette Features: SAFER THAN STEEL - Made of plastic - sturdy yet softer than surgical steel. HANDIER - Each tool has a molded-in thumb indentation instantly orienting the tool. - Easier to maneuver in hard to see places. - Color-coded for easy identification. FASTER - Comes individually packaged in sterile, peel open pouch, ready to go. - Applies, manipulates, or removes cement with fingertip precision. ECONOMICAL - The cost of a single revision dwarfs the cost of a single-use curette. - Disposable – there’s no need to waste time removing hardened cement or re-sterilizing tools. - Less expensive to buy and inventory - order only the tool you use. - Packaged 25 individually wrapped tools to a carton for convenient shelf storage.
Whitney Medical Solutions
OR1201
In Commercial Distribution

  • M266OR12011 ()
  • M266OR12010 ()

  • Width: 6 Millimeter
  • Length: 8 Millimeter
OR1201

  • Orthopaedic cement curette
The Medic Enhancement Set is convenience kit with a capability improvement providing a combination of advanced tools for the management of massive hemorrhage, airway compromise, respiratory system insults and circulatory compromise. • The set is comprised of color coded MARCH protocol devices for rapid visual identification of the appropriate tool required under the MARCH protocol. • Each set is designed to augment or enhance first respondents treatment capacities. TMT-Tourniquet 2 ea Celox Rapid 2 ea iTClamp 1 ea Control-Cric 1 ea Sentinel Chest Seal 2 ea TALON IO Starter Set 1 ea Battle Bandage 2 ea
Safeguard US Operating, LLC
01
In Commercial Distribution

  • M6988250403010 ()
82-504-03

  • First aid kit, non-medicated, single-use
No-Scratch ™ Whitney Valitome ™ is a single-use, sterile, plastic instrument, in the shape of an osteotome, for quickly applying, manipulating, spreading, and removing bone cement during hip and knee replacement surgery. The plastic is softer than steel instruments, reducing the risk of damaging the prosthesis with metal instruments. The Valitome’s 12mm wide tip removes excess cement from replacement hips and knees, and can also be used to apply or spread cement. Easy-to-maneuver, the teal Valitome lets you remove cement from all edges of the prosthesis. No-Scratch Whitney Valitome Features: SAFER THAN STEEL - Made of plastic - sturdy yet softer than surgical steel. HANDIER - Each tool has a molded-in thumb indentation instantly orienting the tool. - Easier to maneuver in hard to see places. - Color-coded for easy identification. FASTER - Comes individually packaged in sterile, peel open pouch, ready to go. - Applies, manipulates, or removes cement with fingertip precision. ECONOMICAL - The cost of a single revision dwarfs the cost of a single-use instrument. - Disposable – there’s no need to waste time removing hardened cement or re-sterilizing tools. - Less expensive to buy and inventory - order only the tool you use. - Packaged 25 individually wrapped tools to a carton for convenient shelf storage.
Whitney Medical Solutions
OR1205
In Commercial Distribution

  • M266OR12051 ()
  • M266OR12050 ()

  • Length: 22 Millimeter
  • Width: 13 Millimeter
OR1205

  • Orthopaedic cement curette
No-Scratch ™ Whitney Sculps Knife ™ is a single-use, plastic instrument for quickly applying, manipulating and removing bone cement during hip and knee replacement surgery. The plastic is softer than steel instruments, reducing the risk of damaging the prosthesis with metal instruments. The Sculps Knife’s 14x20 mm tip removes excess cement from replacement hips and knees. Easy-to-maneuver, the green Sculps Knife lets you remove cement from all edges of the prosthesis. No-Scratch Whitney Sculps Knife Features: SAFER THAN STEEL - Made of plastic - sturdy yet softer than surgical steel. HANDIER - Each tool has a molded-in thumb indentation instantly orienting the tool. - Easier to maneuver in hard to see places. - Color-coded for easy identification. FASTER - Comes individually packaged in sterile, peel open pouch, ready to go. - Applies, manipulates, or removes cement with fingertip precision. ECONOMICAL - The cost of a single revision dwarfs the cost of a single-use instrument like the Sculps Knife. - Disposable – there’s no need to waste time removing hardened cement or re-sterilizing tools. - Less expensive to buy and inventory - order only the tool you use. - Packaged 25 individually wrapped tools to a carton for convenient shelf storage.
Whitney Medical Solutions
OR1203
In Commercial Distribution

  • M266OR12031 ()
  • M266OR12030 ()

  • Width: 14 Millimeter
  • Length: 20 Millimeter
OR1203

  • Orthopaedic cement curette
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