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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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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; Nickel-Cadmium (#72300) Battery; IEC Plug Type-A
WELCH ALLYN, INC.
901081
In Commercial Distribution

  • 00732094089417 ()
11770

  • Ophthalmic/otologic diagnostic set
No Description
BIOMET SPINE LLC
14-524506
In Commercial Distribution

  • 00888480609247 ()

  • LINEUM 4.0MM X 6MM CC SCREW TRANSLATING SCREW LINEUM OCT SPINE SYSTEM
14-524506

  • Bone-screw internal spinal fixation system, non-sterile
OsteoSurge300 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500050
In Commercial Distribution

  • M386565000501 ()
  • 10889981055844 ()

  • 5cc
56500050

  • Bone matrix implant, human-derived
Light Bond™ sealants are intended for use as a light cure sealant resin for bonding under an orthodontic adhesive. This is the 3 cc Filled Sealant Resin with Fluoride.
RELIANCE ORTHODONTIC PRODUCTS INC
LBFSF
In Commercial Distribution

  • D798LBFSF0 ()
LBFSF

  • Dental composite resin
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
Self-Cath Closed System Kit. Soft Tip. Unisex. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Cleansing pad, Gloves and Underpad. Rx only.
Coloplast A/S
50290
In Commercial Distribution

  • 05708932283052 ()
  • 05708932279659 ()

  • Catheter Gauge: 14 French
  • Tip Type Straight/Nelaton
  • Catheter Working Length: 31 Centimeter
  • Catheter Working Length: 12.2 Inch
50290

  • Single-administration urethral catheterization kit, single-use
Accell Evo3 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
02-5000-050
In Commercial Distribution

  • M3860250000501 ()
  • 10889981055400 ()

  • 5cc
02-5000-050

  • Bone matrix implant, human-derived
Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock protective covers.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680002
In Commercial Distribution

  • 50886333600026 ()
  • 00886333600021 ()

  • Coo;ing Coil with 5.5 coils
680002

  • Thermal-dilution cardiac output unit
Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50297
In Commercial Distribution

  • 05708932283083 ()
  • 05708932289344 ()

  • Catheter Gauge: 14 French
  • Tip Type Olive Coudé
  • Catheter Working Length: 12.2 Inch
  • Catheter Working Length: 31 Centimeter
50297

  • Single-administration urethral catheterization kit, single-use
Self-Cath Closed System Kit, Olive Tip. Male. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 16, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
Coloplast A/S
50298
In Commercial Distribution

  • 05708932283090 ()
  • 05708932279680 ()

  • Catheter Gauge: 16 French
  • Tip Type Olive Coudé
  • Catheter Working Length: 12.2 Inch
  • Catheter Working Length: 31 Centimeter
50298

  • Single-administration urethral catheterization kit, single-use
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