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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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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
The Endo Carry-on Procedure Kit includes Endo Carry-on Transport Pad, Sponge, Intercept Bedside Kit, Lubricant, Dirty Scope Label, Gauze Pads, DUOSWIFT Squeegee Brush, and DEFENDO Valves Kit.
MEDIVATORS INC.
102845
In Commercial Distribution

  • 30677964073770 ()
  • 00677964073779 ()
102845

  • Endoscopy preparation kit
Endo Carry-On Procedure kit includes Transport Pad, Intercept Bedside Kit, Sponge, Gauze Pads, Suction Tubing, Gown, Biohazard/Dirty Scope Label and Defendo Single Use Valves and Connector Kit for certain Olympus GI Endoscopes
MEDIVATORS INC.
101960
In Commercial Distribution

  • 30677964072452 ()
  • 00677964072451 ()
  • 00677964072543 ()
101960

  • Endoscopy preparation kit
Box of 10 Velcro Pads
NIMBIC SYSTEMS, INC.
Model 4001
Not in Commercial Distribution

  • 00869284000225 ()
ABS-4001

  • High-efficiency filter air cleaner, mobile
The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded case made of medical grade polycarbonate. The device also includes a Treatment Applicator and an external power supply that are attached to the Control Unit. When not in use, the device is stored inside the carrying case. The device may be removed from the carrying case prior to administration of therapy. Provant Infinity is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.
Regenesis Biomedical, Inc.
4210
Not in Commercial Distribution

  • 00868924000021 ()


  • Deep-tissue electromagnetic stimulation system, home-use
The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy. The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.
Regenesis Biomedical, Inc.
4201
Not in Commercial Distribution

  • 00868924000007 ()


  • Deep-tissue electromagnetic stimulation system, home-use
CVS PUMP PACK
MEDLINE INDUSTRIES, INC.
DYNJ32435J
In Commercial Distribution

  • 40195327208241 ()
  • 10195327208240 ()
DYNJ32435J

  • General surgical procedure kit, non-medicated, single-use
Electronic Pulse Massager - Massager Unit used with pads sold as a single unit per sale.
JKH Health Co., Ltd.
PL-009
In Commercial Distribution

  • 00867587000300 ()
  • 10867587000307 ()


  • Hand-held electric massager
Meijer Tens Replacement Pads
MEIJER, INC.
74-037
In Commercial Distribution

  • 00708820944787 ()
  • 30708820944788 ()
  • 10708820944784 ()
74-037

  • Transcutaneous electrical stimulation electrode, single-use
A set of four triangular foam pads for the Intelli-C X-ray system to be used together with the Patient Support Strap, to support the patient during lateral table tilting movements.
Nrt - Nordisk Røntgen Teknik A/S
21320011
In Commercial Distribution

  • 05713464000305 ()


  • Radiological arm/leg positioner
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