IPPS Overlay MTIL4300

GUDID 00841439105115

Reusable non-sterile overlay for use with Calypso 4D Localization System and Varian Exact base

MEDTEC, INC.

Indexed-immobilization patient positioning system
Primary Device ID00841439105115
NIH Device Record Key36ddf229-be8d-4eb7-aa45-7e1e114ed730
Commercial Distribution Discontinuation2018-08-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIPPS Overlay
Version Model NumberMTIL4300
Catalog NumberMTIL4300
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Dimensions

Width20.8 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439105115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXQTable, radiographic, stationary top

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-08-20
Device Publish Date2017-08-02

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