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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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DISPOSABLE MUCUS TRAP, 40 ML (CC)
CUSTOMED INC
712057052780
In Commercial Distribution

  • M20890027800 ()
  • M20890027802 ()

  • Total Volume: 40 Milliliter
9002780

  • Sputum specimen container IVD
Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
LUCERNO DYNAMICS, LLC
091220-018
In Commercial Distribution

  • 00850014578145 ()
  • 00850014578138 ()
091220-018

  • Hypoallergenic skin adhesive tape
The Prometheus FullStop® tourniquet is a lightweight, durable tourniquet that has been shown to successfully occlude arterial blood flow.
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
PDF181
In Commercial Distribution

  • 05060483570396 ()
PDF181

  • Limb tourniquet, manual, single-use
The Prometheus FullStop® tourniquet is a lightweight, durable tourniquet that has been shown to successfully occlude arterial blood flow.
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED
PDF180
In Commercial Distribution

  • 05060483570389 ()
PDF180

  • Limb tourniquet, manual, single-use
ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution

  • 10888234500261 ()
THROMBOTYPE1

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
The reciprocating microsaw handpiece is intended to be used in oral and maxillofacial surgery for cutting bone and hard tissues.
Bien-Air Dental SA
1601098-001
In Commercial Distribution

  • J00716010980011 ()
1601098-001

  • Surgical power tool system handpiece, sawing, line-powered
Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Huvitz Co., Ltd.
HDR-7000P
In Commercial Distribution

  • 08800019600817 ()
HDR-7000P

  • Phoropter
Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Huvitz Co., Ltd.
HDR-9000
In Commercial Distribution

  • 08800019600213 ()
HDR-9000

  • Phoropter
Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Huvitz Co., Ltd.
HDR-7000
In Commercial Distribution

  • 08800019600206 ()
HDR-7000

  • Phoropter
The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
Ascension Orthopedics, Inc.
DIGIFUSEIMP2
Not in Commercial Distribution

  • M268DIGIFUSEIMP21 ()
  • 10381780074281 ()
DIGIFUSEIMP2

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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