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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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Mjolnir Pro. - 06974223650073

No Description
Shenzhen Leaflife Technology Co., Ltd.
LE-EPSMC
In Commercial Distribution

  • 06974223650073 ()


  • Electrosurgical handpiece, single-use

LapBox Power - 07290118830023

The LapBox Power Contained Tissue Extraction System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be power morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
ARK SURGICAL LTD
ARK-P01
In Commercial Distribution

  • 07290118830023 ()
  • 07290118830030 ()


  • Tissue extraction bag

Vital Signs™ - 10190752148697

Power Handle
VYAIRE MEDICAL, INC.
3950
In Commercial Distribution

  • 50190752148695 ()
  • 10190752148697 ()
3950

  • Artificial airway stylet, single-use

EVEREST Spinal System - 10888857561762

Power Adapter
K2M, INC.
PRO-1300
In Commercial Distribution

  • 10888857561762 ()
PRO-1300

  • Drilling power tool attachment, basic

Minitouch - 00850044503155

Power Cord
Microcube, LLC
4006
In Commercial Distribution

  • 00850044503155 ()


  • Microwave ablation system

N/A - 00849044065824

Power Bender
GLOBUS MEDICAL, INC.
634.506
In Commercial Distribution

  • 00849044065824 ()


  • Manual orthopaedic bender, reusable

Shaver System - 00850002250169

Power Cord
STRYKER CORPORATION
SSA-103
Not in Commercial Distribution

  • 00850002250169 ()


  • Electrical mains power cable

Flyte - 04546540591586

Power Cord
STRYKER CORPORATION
0408600300
In Commercial Distribution

  • 04546540591586 ()
0408-600-300

  • Surgical helmet system

HeartMate™ - 05415067039545

Power Module
Thoratec Corporation
1340
In Commercial Distribution

1340

  • Basic power supply, reusable

SJM™ - 05415067018038

Power Supply
ST. JUDE MEDICAL, INC.
H701803
In Commercial Distribution

  • 05415067018038 ()
H701803

  • Electrical-only medical device connection cable, reusable
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