A reference standard device intended to represent one end of a medical quick-connect coupling or a terminal unit of a gas-specific format [e.g., oxygen (O2), nitrous oxide (N2O), medical air], which may be used to evaluate connection port compatibility and ...

External lower-limb prosthesis structural/alignment component

226 GUDID devices

A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint pr...

Evoked-potential graphic recording system

151 GUDID devices

An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from t...

Dura mater graft, bovine

92 GUDID devices

A xenograft made from bovine dura mater or bovine pericardium used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps...

Vitreous/aqueous humour replacement medium, intraoperative

64 GUDID devices

A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during ...

Dura mater biomatrix implant

59 GUDID devices

A bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of t...

Dura mater biomatrix implant

54 GUDID devices

A sterile device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dur...

Microscopy mounting medium IVD

38 GUDID devices

A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.

Dura mater graft, synthetic

32 GUDID devices

A sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent repair or replacement of the dura mater in a recipient during a neurosurgical proc...

Orthopaedic fixation plate bending insert, reusable

31 GUDID devices

A device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvi...

Surgical water bath system

18 GUDID devices

An assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) wate...

Orthopaedic fixation plate bending insert, single-use

17 GUDID devices

A non-sterile device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawb...

Dura mater graft, bioengineered

11 GUDID devices

A sterile device made from bioengineered materials (e.g., cellulose fibres produced by microorganisms) used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrit...

Orthopaedic knee-balance analyser

11 GUDID devices

A mechanical orthopaedic measuring/testing instrument used by a surgeon during the procedure to interrogate the strength and integrity of the ligaments that support (balance) the knee, prior to bony resection for a total knee arthroplasty (TKA). This may pr...

Vascular irrigation cannula, cardiac vessel graft

10 GUDID devices

A sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots...

Haidinger brush imager

8 GUDID devices

A mains electricity (AC-powered) ophthalmic device designed to produce an image consisting of two conical brush-like images with apexes touching (known as Haidinger brushes). The observation of the image characteristics by a patient through a Nicole prism f...

Cochlear implant assessment system

5 GUDID devices

An assembly of non-sterile portable electronic devices designed to perform an integrity test on the implantable portion of a cochlear implant (CI) system in situ; the test is intended to provide objective data on implant function and aid in the assessment o...

Heater/cooler system tester kit

5 GUDID devices

A collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The k...

Hearing implant implantable-component tester, postoperative

4 GUDID devices

A portable electronic device designed to perform an integrity test on the implantable portion of a hearing implant [e.g., cochlear implant (CI)] system in situ postoperatively (e.g., during routine checks); the test is intended to provide objective data on ...

Tracheal pilot tube repair kit

4 GUDID devices

A collection of devices designed to restore the integrity of a damaged endotracheal (ET)/tracheostomy pilot tube when it is no longer maintaining the tracheal cuff pressure. Such a repair can deter the need to replace the entire endotracheal/tracheostomy tu...

Hyaluronan binding sperm selection device

1 GUDID devices

A device intended to be used for the in vitro selection of mature (hyaluronan-binding) sperm to treat infertile couples by intracytoplasmic sperm injection (ICSI). It typically consists of a plastic culture dish with microdots of hyaluronan hydrogel attache...

Ophthalmic infusion cannula

1 GUDID devices

A rigid tube designed to instill fluids [e.g., balanced salt solution (BSS), silicone oil] into the interior of the eye during ophthalmic surgery, typically to maintain the structural integrity of the eye after the procedure. It is typically made of high-gr...