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.
ZILOS-tk
In Commercial Distribution

  • 00858604006276 ()


  • Assisted reproduction laser system
Elastic Therapeutic Tape / Kinesiology Tape
Kinesio Holding Corporation
CKTM95024
In Commercial Distribution

  • 10858474006571 ()
  • 00858474006574 ()

  • 5cm (2 inches)
  • Width: 5 Centimeter
  • Length: 5 Meter
  • 5 Meters (16.4 feet)
CKTM95024

  • Adhesive bandage
No Description
SURGENTEC, LLC
3D-D05-07
In Commercial Distribution

  • 00858406007709 ()


  • Bone file/rasp, manual, reusable
DR. OULETTE BLADE PACK
MEDLINE INDUSTRIES, INC.
DYNDA2226
In Commercial Distribution

  • 10889942883530 ()
  • 40889942883531 ()
DYNDA2226

  • General surgical procedure kit, non-medicated, single-use
Mini Pinktini + Optimizing Mist + Black Pouch
Nuface
QVC40830
In Commercial Distribution

  • 00858398007121 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Mini White + Optimizing Mist + Black Pouch
Nuface
QVC40820
In Commercial Distribution

  • 00858398007114 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Mini Silver + Optimizing Mist + Black Pouch
Nuface
QVC40840
In Commercial Distribution

  • 00858398007107 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
LID PERFORATED - BLACK 310X190MM
BAHADIR USA LLC
Y500.06A
In Commercial Distribution

  • 00858307007266 ()


  • Device sterilization/disinfection container, reusable
LID PERFORATED - BLACK 300X140MM
BAHADIR USA LLC
Y400.06A
In Commercial Distribution

  • 00858307007211 ()


  • Device sterilization/disinfection container, reusable
LID PERFORATED - BLACK 285X280MM
BAHADIR USA LLC
Y 300.06
In Commercial Distribution

  • 00858307007167 ()


  • Device sterilization/disinfection container, reusable
LID PERFORATED - BLACK 465X280MM
BAHADIR USA LLC
Y 200.06
In Commercial Distribution

  • 00858307007112 ()


  • Device sterilization/disinfection container, reusable
LID PERFORATED - BLACK 600X400MM
BAHADIR USA LLC
Y100.56
In Commercial Distribution

  • 00858307007068 ()


  • Device sterilization/disinfection container, reusable
LID PERFORATED - BLACK 580X280MM LID PERFORATED - YELLOW 580X280MM
BAHADIR USA LLC
Y100.06
In Commercial Distribution

  • 00858307007013 ()


  • Device sterilization/disinfection container, reusable
BP Cuff, Adult Lg, 2 tube BP00-2205 = 5 pack
REPROCESSING PRODUCTS CORPORATION
BP00-2201
In Commercial Distribution

  • 00858293006915 ()
  • 10858293006912 ()


  • Blood pressure cuff, reusable
BP Cuff, Thigh, 42-50 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST4250FLC
In Commercial Distribution

  • 10858293006660 ()
  • 00858293006663 ()


  • Blood pressure cuff, single-use
BP Cuff, Thigh, 42-50 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST4250FL
In Commercial Distribution

  • 10858293006653 ()
  • 00858293006656 ()


  • Blood pressure cuff, single-use
BP Cuff, Large Adult Long, 35-44 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST3544FLC
In Commercial Distribution

  • 10858293006646 ()
  • 00858293006649 ()


  • Blood pressure cuff, single-use
BP Cuff, Large Adult Long, 35-44 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST3544FL
In Commercial Distribution

  • 10858293006639 ()
  • 00858293006632 ()


  • Blood pressure cuff, single-use
BP Cuff, Large Adult, 32-42 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST3242FLC
In Commercial Distribution

  • 10858293006622 ()
  • 00858293006625 ()


  • Blood pressure cuff, single-use
BP Cuff, Large Adult, 32-42 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST3242FL
In Commercial Distribution

  • 10858293006615 ()
  • 00858293006618 ()


  • Blood pressure cuff, single-use
BP Cuff, Long Adult, 29-38 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST2938FLC
In Commercial Distribution

  • 10858293006608 ()
  • 00858293006601 ()


  • Blood pressure cuff, single-use
BP Cuff, Long Adult, 29-38 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST2938FL
In Commercial Distribution

  • 10858293006592 ()
  • 00858293006595 ()


  • Blood pressure cuff, single-use
BP Cuff, Regular Adult, 26-35 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST2635FLC
In Commercial Distribution

  • 10858293006585 ()
  • 00858293006588 ()


  • Blood pressure cuff, single-use
BP Cuff, Regular Adult, 26-35 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST2635FL
In Commercial Distribution

  • 10858293006578 ()
  • 00858293006571 ()


  • Blood pressure cuff, single-use
BP Cuff, Small Adult, 18-26 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST1826FLC
In Commercial Distribution

  • 10858293006561 ()
  • 00858293006564 ()


  • Blood pressure cuff, single-use
BP Cuff, Small Adult, 18-26 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST1826FL
In Commercial Distribution

  • 10858293006554 ()
  • 00858293006557 ()


  • Blood pressure cuff, single-use
BP Cuff, Child, 13-20 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST1320FLC
In Commercial Distribution

  • 10858293006547 ()
  • 00858293006540 ()


  • Blood pressure cuff, single-use
BP Cuff, Child, 13-20 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST1320FL
In Commercial Distribution

  • 10858293006530 ()
  • 00858293006533 ()


  • Blood pressure cuff, single-use
BP Cuff, Infant, 8-14 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST0814FLC
In Commercial Distribution

  • 10858293006523 ()
  • 00858293006526 ()


  • Blood pressure cuff, single-use
BP Cuff, Infant, 8-14 cm, 1 Tube
REPROCESSING PRODUCTS CORPORATION
ST0814FL
In Commercial Distribution

  • 10858293006516 ()
  • 00858293006519 ()


  • Blood pressure cuff, single-use
Black Tubing, PVC. 1/8 in. - 1/4 in.
REPROCESSING PRODUCTS CORPORATION
BT00-0103
In Commercial Distribution

  • 00858293006502 ()


  • Vacuum hose
Black Tubing, Natural, 3/16 in. - 3/8 in
REPROCESSING PRODUCTS CORPORATION
BT00-0100
In Commercial Distribution

  • 00858293006496 ()


  • Vacuum hose
BP Cuff, Adult Thigh, 1 Tube BP00-3105 = 5 pack
REPROCESSING PRODUCTS CORPORATION
BP00-3101
In Commercial Distribution

  • 10858293006448 ()
  • 00858293006441 ()


  • Blood pressure cuff, reusable
BP Cuff, Adult Large, 1 Tube BP00-2105 = 5 pack BP00-2120 = 20 pack
REPROCESSING PRODUCTS CORPORATION
BP00-2101
In Commercial Distribution

  • 20858293006438 ()
  • 00858293006434 ()
  • 10858293006431 ()


  • Blood pressure cuff, reusable
BP Cuff, Adult Regular, 1 tube BP00-1105 = 5 pack BP00-1120 = 20 pack
REPROCESSING PRODUCTS CORPORATION
BP00-1101
In Commercial Distribution

  • 20858293006421 ()
  • 00858293006427 ()
  • 10858293006424 ()


  • Blood pressure cuff, reusable
BP Cuff, Adult Sm, 1 tube BP00-0105 = 5 pack BP00-0120 = 20 pack
REPROCESSING PRODUCTS CORPORATION
BP00-0101
In Commercial Distribution

  • 20858293006414 ()
  • 00858293006410 ()
  • 10858293006417 ()


  • Blood pressure cuff, reusable
Patient Armor BLACK PF Nitrile Exam Gloves (XL) - 100/Bx
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
XL
In Commercial Distribution

  • 00858653006746 ()
PA205

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS10000
In Commercial Distribution

  • 10858629005039 ()
  • 00858629005032 ()
SMS10000

  • Sharps container
3.3 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS2400
In Commercial Distribution

  • 10858629005015 ()
  • 00858629005018 ()
SMS2400

  • Sharps container
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
In Commercial Distribution

  • 00858604006290 ()


  • Assisted reproduction laser system
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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