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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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Self-Cath Closed System Kit. Straight Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 8, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50260
In Commercial Distribution

  • 05708932282895 ()
  • 05708932279130 ()

  • Catheter Gauge: 8 French
  • Catheter Working Length: 31 Centimeter
  • Catheter Working Length: 12.2 Inch
  • Tip Type Straight/Nelaton
50260

  • Single-administration urethral catheterization kit, single-use
Welch Allyn 3.5 V Halogen HPX Ophthalmoscope Set with Coaxial Ophthalmoscope (#11720), Rechargeable 60-Minute Power Handle(s) -- C-C ell Convertible, Hard Storage Case, C-Cell Battery Converter Accessory; Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F
WELCH ALLYN, INC.
901081
In Commercial Distribution

  • 00732094019643 ()
11772-VC

  • Ophthalmic/otologic diagnostic set
OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
2.5cc
In Commercial Distribution

  • 07350086550726 ()

  • Total Volume: 2.5 Milliliter


  • Bone matrix implant, synthetic, non-antimicrobial
OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
5cc
In Commercial Distribution

  • 07350086550719 ()

  • Total Volume: 5 Milliliter
104050

  • Bone matrix implant, synthetic, non-antimicrobial
OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Ossdsign AB
10cc
In Commercial Distribution

  • 07350086550702 ()

  • Total Volume: 10 Milliliter
104100

  • Bone matrix implant, synthetic, non-antimicrobial
BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder.
Philips Ds North America LLC
9896-031-10735
In Commercial Distribution

  • 00884838115255 ()


  • MRI system coil, radio-frequency
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use
Peel-Away Introducer Set, 10.5F
Oscor Inc.
AP10516
In Commercial Distribution

  • 00836559006800 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
  • Needle Gauge: 18 Gauge
  • Dilator Length 19 cm
  • Syringe 10 cc
  • Guidewire Length 50 cm, OD: 0.038 in
  • Sheath Length 16 cm
AP10516

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 10F
Oscor Inc.
AP10016
In Commercial Distribution

  • 00836559006794 ()

  • Lumen/Inner Diameter: 3.3 Millimeter
  • Dilator Length 19 cm
  • Needle Gauge: 18 Gauge
  • Guidewire Length 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Sheath Length 16 cm
AP10016

  • Vascular catheter introduction set, nonimplantable
Peel-Away Introducer Set, 9F
Oscor Inc.
AP09016
In Commercial Distribution

  • 00836559006770 ()

  • Sheath Length 16 cm
  • Guidewire Length 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 3 Millimeter
  • Needle Gauge: 18 Gauge
  • Syringe 10 cc
  • Dilator Length 19 cm
AP09016

  • Vascular catheter introduction set, nonimplantable
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