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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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Coeur - M297702110

200mL Front Load Ct-Pack with Coiled Line
COEUR, INC.
C853-0211
In Commercial Distribution

  • M297702116 ()
  • M297702110 ()

  • Total Volume: 200 Milliliter
C853-0211

  • Angiographic syringe

Coeur - M297701550

Coeur 150mL Syringe w/ J tube
COEUR, INC.
C853-0155
In Commercial Distribution

  • M29701556 ()
  • M297701550 ()

  • Total Volume: 150 Milliliter
C853-0155

  • Angiographic syringe

Coeur - M297701270

Coeur 125mL Dual Syringe Pack
COEUR, INC.
C853-0127
In Commercial Distribution

  • M297701276 ()
  • M297701270 ()

  • Total Volume: 125 Milliliter
C853-0127

  • Angiographic syringe

Coeur - M297701250

125mL syringe Angiographic/CT
COEUR, INC.
C853-0125
In Commercial Distribution

  • M297701256 ()
  • M297701250 ()

  • Total Volume: 125 Milliliter
C853-0125

  • Angiographic syringe

Coeur - M297700660

Disposable Syringe Kit :(1-60mL syringe, 1-Spike)
COEUR, INC.
C853-0066
In Commercial Distribution

  • M297700666 ()
  • M297700660 ()

  • Total Volume: 60 Milliliter
C853-0066

  • Angiographic syringe

Whitney No-Scratch Valitome - M266OR12050

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

Whitney No-Scratch Curette (Small) - M266OR12010

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

eShield Digital Camera Size - M266EC22000

The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Whitney Medical Solutions
EC2200
Not in Commercial Distribution

  • M266EC22001 ()
  • M266EC22000 ()


  • Patient surgical drape, single-use

eShield Cell Phone Size - M266EC21000

The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide that allows the cover to be torn fairly straight across it. There is also a double sided tape that is used as a closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
Whitney Medical Solutions
EC2100
In Commercial Distribution

  • M266EC21001 ()
  • M266EC21000 ()

  • Width: 36 Centimeter
  • Depth: 22 Centimeter
  • Width: 23 Centimeter
  • Depth: 11 Centimeter


  • Medical equipment drape, single-use

LabTron - M3682421

Home Blood Pressure Kit
GF HEALTH PRODUCTS, INC.
242
In Commercial Distribution

  • M3682422 ()
  • M3682421 ()


  • Aneroid manual sphygmomanometer
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