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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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LabTron - M368165NBL1

Standard Sphygmomanometer
GF HEALTH PRODUCTS, INC.
165NBL
In Commercial Distribution

  • M368165NBL2 ()
  • M368165NBL1 ()


  • Aneroid manual sphygmomanometer

GRAFCO - M3681565C41

Medicopaste Bandage with Calamine
GF HEALTH PRODUCTS, INC.
1565C-4
In Commercial Distribution

  • M3681565C42 ()
  • M3681565C41 ()


  • Adhesive bandage

GRAFCO - M3681565C31

Medicopaste Bandage with Calamine
GF HEALTH PRODUCTS, INC.
1565C-4
In Commercial Distribution

  • M3681565C32 ()
  • M3681565C31 ()


  • Adhesive bandage

GRAFCO - M368156541

Medicopaste Bandage
GF HEALTH PRODUCTS, INC.
1565 4
In Commercial Distribution

  • M368156542 ()
  • M368156541 ()


  • Adhesive bandage

GRAFCO - M368156531

Medicopaste Bandage
GF HEALTH PRODUCTS, INC.
1565 3
In Commercial Distribution

  • M368156532 ()
  • M368156531 ()


  • Adhesive bandage

LUMEX - M368140251

Alternating Pressure/Low Air Loss Overlay System
GF HEALTH PRODUCTS, INC.
14025
In Commercial Distribution

  • M368140252 ()
  • M368140251 ()


  • Alternating-pressure bed mattress overlay system

LUMEX - M368136351

Pocket Goniometer
GF HEALTH PRODUCTS, INC.
13635
In Commercial Distribution

  • M368136352 ()
  • M368136351 ()


  • Manual goniometer

LUMEX - M368136301

Pocket Goniometer
GF HEALTH PRODUCTS, INC.
13630
In Commercial Distribution

  • M368136302 ()
  • M368136301 ()


  • Manual goniometer

Labtron - M368122731

Ophthalmoscope Otoscope Set
GF HEALTH PRODUCTS, INC.
1227-3
In Commercial Distribution

  • M368122732 ()
  • M368122731 ()
1227-3

  • Direct ophthalmoscope

LABTRON - M368122711

Otoscope Set
GF HEALTH PRODUCTS, INC.
1227-1
In Commercial Distribution

  • M368122712 ()
  • M368122711 ()


  • Otoscope, direct

LUMISCOPE - M368100001TH1

Professional Aneroid Sphygmomanometer Thigh
GF HEALTH PRODUCTS, INC.
100-001TH
In Commercial Distribution

  • M368100001TH2 ()
  • M368100001TH1 ()


  • Aneroid manual sphygmomanometer

LUMISCOPE - M368100001NCHI1

Professional Aneroid Sphygmomanometer Child
GF HEALTH PRODUCTS, INC.
100-001NCHI
In Commercial Distribution

  • M368100001NCHI2 ()
  • M368100001NCHI1 ()


  • Aneroid manual sphygmomanometer

LUMISCOPE - M368100001LA1

Professional Aneroid Sphygmomanometer Large
GF HEALTH PRODUCTS, INC.
100-001LA
In Commercial Distribution

  • M36810001LA2 ()
  • M368100001LA1 ()


  • Aneroid manual sphygmomanometer

LUMISCOPE - M368100001INF1

Professional Aneroid Sphygmomanometer Infant
GF HEALTH PRODUCTS, INC.
100-001INF
In Commercial Distribution

  • M368100001INF2 ()
  • M368100001INF1 ()


  • Aneroid manual sphygmomanometer

Coeur - M297761500

150mL A-Series Syringe
COEUR, INC.
C853-6150
In Commercial Distribution

  • M297761506 ()
  • M297761500 ()

  • Total Volume: 150 Milliliter
C853-6150

  • Angiographic syringe

Coeur - M297732010

200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" Y-line, and 2-Spikes
COEUR, INC.
C853-3201
In Commercial Distribution

  • M297732016 ()
  • M297732010 ()

  • Total Volume: 400 Milliliter
C853-3201

  • Angiographic syringe

Coeur - M297702320

200mL Front Load CT Syringe with Fill Tube
COEUR, INC.
C853-0232
In Commercial Distribution

  • M297702326 ()
  • M297702320 ()

  • Total Volume: 200 Milliliter
C853-0232

  • Angiographic syringe

Coeur - M297702100

Coeur 200mL Syringe
COEUR, INC.
C853-0210
In Commercial Distribution

  • M297702106 ()
  • M297702100 ()

  • Total Volume: 200 Milliliter
C853-0210

  • Angiographic syringe

Coeur - M297701300

130mL Angiographic Syringe includes (1) J-Tube
COEUR, INC.
C853-0130
In Commercial Distribution

  • M297701306 ()
  • M297701300 ()

  • Total Volume: 130 Milliliter
C853-0130

  • Angiographic syringe

Coeur - M297701260

125mL Syringe Angiographic/CT
COEUR, INC.
C853-0126
In Commercial Distribution

  • M297701266 ()
  • M297701260 ()

  • Total Volume: 125 Milliliter
C853-0126

  • Angiographic syringe

Coeur - M297700780

MR Syringe Dual Pack (Includes; 2-60mL Syringes, 2-Lateral Flow Needle Spike, and 1-96" Y-Line with 2 Check Valves)
COEUR, INC.
C853-0078
In Commercial Distribution

  • M297700780 ()
  • M297700786 ()

  • Length: 96 Inch
  • Total Volume: 60 Milliliter
C853-0078

  • Angiographic syringe

Whitney No-Scratch Sculps Knife - M266OR12030

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

Whitney No-Scratch Curette (Large) - M266OR12020

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

eShield SLR Camera Size - M266EC24000

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, along with sterile rubber bands to allow an SLR camera lens to be held securely against the wall of the cover. The device 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
EC2400
In Commercial Distribution

  • M266EC24001 ()
  • M266EC24000 ()

  • Width: 36 Centimeter
  • Depth: 22 Centimeter


  • Medical equipment drape, single-use

eShield Tablet Size - M266EC23000

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
EC2300
In Commercial Distribution

  • M266EC23001 ()
  • M266EC23000 ()

  • Width: 36 Centimeter
  • Depth: 22 Centimeter


  • Medical equipment drape, single-use

PlasmaJet Neutral Plasma Surgery System - M397OSCP05120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-12
In Commercial Distribution

  • M397OSCP05120 ()
  • M397OSCP05122 ()

  • Length: 12 Centimeter
OS-CP-05-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCP0507H0

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP 05-07H
In Commercial Distribution

  • M397OSCP0507H2 ()
  • M397OSCP0507H0 ()

  • Length: 07 Centimeter
OS-CP 05-07H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCP05070

Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-07
In Commercial Distribution

  • M397OSCP05070 ()
  • M397OSCP05072 ()

  • Length: 7 Centimeter
OS-CP-05-07

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG0512H0

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG 05-12H
In Commercial Distribution

  • M397OSCG0512H2 ()
  • M397OSCG0512H0 ()

  • Length: 12 Centimeter
OS-CG 05-12H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG05120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG-05-12
In Commercial Distribution

  • M397OSCG05120 ()
  • M397OSCG05122 ()

  • Length: 12 Centimeter
OS-CG-05-12

  • Plasma surgical system handpiece
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