KLARITY MEDICAL

GUDID 00817355023529

Complete Glass Fibre SBRT System, including Baseplate, Wingboard, T-Bar, 2 Arches, 2 Vacuum Bags, knee cushion and feet cushion.

KLARITY MEDICAL PRODUCTS, LLC

Indexed-immobilization patient positioning system
Primary Device ID00817355023529
NIH Device Record Key54b2af7e-c046-49db-8276-99f3ede36cf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameKLARITY MEDICAL
Version Model NumberR62400-GF
Company DUNS034824691
Company NameKLARITY MEDICAL PRODUCTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817355023529 [Primary]

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-13
Device Publish Date2018-06-12

On-Brand Devices [KLARITY MEDICAL]

00817355023826Klarity Green IMRT Open Face Profile Frame Head Mask 3.2mm, AccuPerf (Reinforced) Extended Neckl
00817355023819Klarity Coated Mat 65.2cm x 52.0cm x 2.2cm
00817355023802Klarity Reloadable Head Mask 3.2mm, 9x10" Perf 42% for S-Type
00817355023796MR WingSpan™ Baseplate with T-Hand Grips fiberglass
00817355023789(Custom Nicewonder) Vacuum Bag for Body Support 100x70cm 20 liter fill Civco Type Valve with Ind
00817355023772Klarity AccuCushion™ 25x35cm with Rounded Head area
00817355023765PelvicFix™ Bodycast with disposable frame solid 3.2mm, 46x56cm
00817355023758PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm
00817355023741PelvicFix™ Bodycast with disposable frame solid 2.4mm, 46x56cm
00817355023734Vacuum Bag for Body Support 33 liter fill, 120x80cm with Civco Type Valve
00817355023727Vacuum Bag for Body Support, 100x70cm, 40 liter fill, with Civco Type Valve
00817355023710Green Stereotactic Head & Shoulder Frame Mask Set Type B
00817355023703LiteGreen™ O-type 3-Point Head Mask with AccuPerf™ 2.4mm
00817355023680Klarity BiteLok™: complete package with BiteLok™, dental putty, QuickFit™ tool, and tongue
00817355023673Custom Rounded Corner Head and Shoulder AccuCushion for BOS Type Proton Boards 63x46cm for Eberh
00817355023666Custom Rounded Corner AccuCushion™ for Head Support, 20x25cm for Eberhard Medizintechnik
00817355023659Custom Rounded Corner AccuCushion™ for Head Support, 20x25cm for Eberhard Medizintechnik
00817355023642( Custom MD Anderson) Vacuum Bag for Body Support 170x60cm 35 liter fill with Civco Type Valve,
00817355023635Custom Rounded Corner Head & Shoulder Extended AccuCushion™, 46x47 cm for Eberhard Medizintech
00817355023628Vacuum Bag for SBRT Leg Fixation Bridge
00817355023611Vacuum Bag for Body Support 120x70cm 30 liter fill Civco Type Valve
00817355023604Custom Rounded Corner Pediatric Head & Shoulder AccuCushion™ with neck bump, 30x36cm for Eberh
00817355023598Vacuum Bag for Body Support 120x70cm 30 liter fill No Valve
00817355023581Klarity 1/8" (3.2mm), 36"x24" (920x610mm) Perf 42%
00817355023574Klarity 3/32" (2.4mm), 36"x24" (920mmX610mm) Non Perf
00817355023567Klarity-R™ Sheet solid 1.6mm, 460x610mm
00817355023550Klarity SOLO, 1/8"(3.2mm), 36"x24"(920x610mm) Non Perf
00817355023543Carbon fiber Head Support (A-F Set)
00817355023536Respiratory Restraint Belt
00817355023529Complete Glass Fibre SBRT System, including Baseplate, Wingboard, T-Bar, 2 Arches, 2 Vacuum Bags
00817355023512Upper Body Vacuum Bag for SBRT System
00817355023505Complete Multifix™ Baseplate System, 540mmx1332mm
00817355023499Set of one Kneefix cushion and two Knee Elevation Blocks
00817355023482Vacuum Bag for Body Support 20 liter fill, 100x100cm
00817355023475Dana Farber Custom Vacuum Bag for Body Support 30 liter fill, 150x75cm
00817355023468Dana Farber Vacuum Bag for Body Support 17.5 liter fill, 100x70cm with Civco Type Valve
00817355023451Vacuum Bag for SBRT 90x136.5 cm 32.5 liter fill, with index bar, Civco type valve
00817355023444Dana Farber Vacuum Bag for Body Support 17.5 liter fill, 100x70cm with Civco Type Valve
00817355023437Custom Rounded Corner Pediatric Head & Shoulder AccuCushion™, 30x36cm for Eberhard Medizintech
00817355023420Custom Rounded Corner AccuCushion™ for Head Support, 15x20cm for Eberhard Medizintechnik
00817355023413Insert-Lock Aluminum Indexing Bar for iBEAM®, Novalis, and TomoTherapy® Couch Tops 3 mm thickn
00817355023406Insert-Lock Plastic Indexing Bar for iBEAM®, Novalis, and TomoTherapy® Couch Tops 6 mm thickne
00817355023390Spring-Lock Aluminum Indexing Bar for Exact™ Couch Top 3 mm thickness
00817355023383Turn-Lock Plastic Indexing Bar for Exact™ Couch Top 6 mm thickness MR Safe
00817355023376Turn-Lock Aluminum Indexing Bar for Exact™ Couch Top 3 mm thickness
00817355023369Custom Rounded Corner AccuCushion™ for Head Support, 20x40cm Eberhard Medizintechnik
00817355023352Green S-type OpenFace Head & Shoulder Mask with AccuPerf™ 3.2mm
00817355023345Vacuum Bag for SBRT 32.5 liter fill, with index bar No Valve
00817355023338LiteGreen™ O-Type 5-Point OpenFace Head & Shoulder Mask, 2.4mm
00817355023314Insert-Lock Aluminum Indexing Bar for iBEAM®, Novalis, and TomoTherapy® Couch Tops 3 mm thickn
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