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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
2 Gallon Sekurit Red Slant Top Sharps Container.
STERICYCLE, INC.
2S1-002FG
In Commercial Distribution

  • 00858775006310 ()


  • Sharps container
2 Gallon Washington Pharmaceutical Reusable Sharps Container-Blue
STERICYCLE, INC.
C-02BRX-0203-WA
In Commercial Distribution

  • 00858775006273 ()


  • Sharps container
8 Gallon Washington Pharmaceutical Reusable Sharps Container-Blue
STERICYCLE, INC.
C-08BLUEWA-PH
In Commercial Distribution

  • 00858775006228 ()


  • Sharps container
8 Gallon Reusable Sharps Container-Red
STERICYCLE, INC.
C-08-2004
In Commercial Distribution

  • 00858775006204 ()


  • Sharps container
4 Gallon California Pharmaceutical Reusable Sharps Container-Blue
STERICYCLE, INC.
C-04BLUECAL-PH
In Commercial Distribution

  • 00858775006181 ()


  • Sharps container
3 Gallon Reusable Sharps Container-Red
STERICYCLE, INC.
C-03RES-0203
In Commercial Distribution

  • 00858775006105 ()


  • Sharps container
3 Gallon Sekurit Red Sharps Container
STERICYCLE, INC.
301-001FG
In Commercial Distribution

  • 00858775006082 ()

  • Total Volume: 3 Gallon


  • Sharps container
2 Gallon Sekurit Red Slant Top Sharps Container
STERICYCLE, INC.
2S1-001FG
In Commercial Distribution

  • 00858775006075 ()

  • Total Volume: 2 Gallon


  • Sharps container
1.5 Gallon Sekurit Red Sharps Container
STERICYCLE, INC.
151-001FG
In Commercial Distribution

  • 00858775006051 ()

  • Total Volume: 1.5 Gallon


  • Sharps container
1.4 Quart White Safe Returns Sharps Container
STERICYCLE, INC.
14101-002ST
In Commercial Distribution

  • 00858775006013 ()

  • Total Volume: 1.4 Quart


  • Sharps container
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-8051
In Commercial Distribution

  • 00858736006168 ()
7013-8051

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-9050
In Commercial Distribution

  • 00858736006090 ()
7013-9050

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5812 BLADE
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5812
In Commercial Distribution

  • 00858736006083 ()
  • 00858736006212 ()
7023-5812

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5710
In Commercial Distribution

  • 00858736006069 ()
  • 00858736006175 ()
7013-5710

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 10
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5710
In Commercial Distribution

  • 00858736006052 ()
  • 00858736006175 ()
7023-5710

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 10
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7023-5715
In Commercial Distribution

  • 00858736006038 ()
  • 00858736006137 ()
7023-5715

  • Haemostatic knife
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-8400
In Commercial Distribution

  • 00858736006014 ()
7013-8400

  • Haemostatic knife
The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
1.0
In Commercial Distribution

  • 00858733006338 ()
  • 00858733006345 ()
MI-XCHM-651

  • Surgical soft-tissue manipulation forceps, scissors-like, single-use
The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Quick Release.
Biorep Technologies, Inc.
1.0
In Commercial Distribution

  • 00858733006291 ()
MI-XCQR-001

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
1.0
In Commercial Distribution

  • 00858733006284 ()
MI-XCDD-001

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
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