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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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This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.
HAMILTON THORNE, INC.
LYKOS DTS
In Commercial Distribution

  • 00858604006054 ()


  • Assisted reproduction laser system
DR ROBINSON BLADE PACK
MEDLINE INDUSTRIES, INC.
DYNDA2227
In Commercial Distribution

  • 10889942890590 ()
  • 40889942890591 ()
DYNDA2227

  • General surgical procedure kit, non-medicated, single-use
Elastic Therapeutic Tape / Kinesiology Tape
Kinesio Holding Corporation
PKT95024-L
In Commercial Distribution

  • 20858474006035 ()
  • 10858474006038 ()
  • 00858474006031 ()

  • Width: 5 Centimeter
  • 5cm (2 inches)
  • 5 Meters (16.4 feet)
  • Length: 5 Meter
PKT95024-L

  • Adhesive bandage
The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. Inserted on this tubing is a yellow foam seal and a black positioning ring that can both slide along the tubing. A spare larger foam seal and a male connector are also supplied. When surgery is performed in one nasal cavity, the AeroClear is placed in the contralateral cavity and connected to facility suction.
HEMOSTASIS, LLC
9770013
Not in Commercial Distribution

  • 00858439001774 ()
  • 00858439001781 ()
  • 00858439001798 ()


  • Surgical/emergency suction cannula, non-illuminating, single-use
ENDO BLADDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ49672G
In Commercial Distribution

  • 10889942884421 ()
DYNJ49672G

  • General surgical procedure kit, non-medicated, single-use
Qty 1 - 15610002 - Emerald Scanner (OY) Qty 1 - 15600102 - Emerald Scanner Accessories (Includes 1 Scanner Cable, 1 Color Blancer, 3 Tips)
D4D TECHNOLOGIES, LLC
15600002 Emerald Scanner Kit - OY
Not in Commercial Distribution

  • 00858809006149 ()
  • 00858809006163 ()


  • Dental milling system, CAD/CAM, chairside
Urinary Drainage Collection Kit without Catheter
FOOTPRINT MEDICAL, INC.
UDKNC
In Commercial Distribution

  • 10858778006499 ()
  • 00858778006492 ()


  • Urethral catheterization support kit, urinary drainage
8.0Fr Silicone Urinary Drainage Kit with Catheter
FOOTPRINT MEDICAL, INC.
S1UDK8.0
In Commercial Distribution

  • 10858778006482 ()
  • 00858778006485 ()

  • Catheter Gauge: 8.0 French


  • Single-administration urethral drainage catheter
6.5Fr Silicone Urinary Drainage Kit with Catheter
FOOTPRINT MEDICAL, INC.
S1UDK6.5
In Commercial Distribution

  • 10858778006475 ()
  • 00858778006478 ()

  • Catheter Gauge: 6.5 French


  • Single-administration urethral drainage catheter
3.5Fr Silicone Urinary Drainage Catheter
FOOTPRINT MEDICAL, INC.
S1UDC3.5
In Commercial Distribution

  • 10858778006413 ()
  • 00858778006416 ()

  • Catheter Gauge: 3.5 French


  • Single-administration urethral drainage catheter
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