Wedge and Spacer Set 107106

GUDID 00841439111086

2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer

MEDTEC, INC.

Radiological headrest
Primary Device ID00841439111086
NIH Device Record Keyebbf595f-256f-41bc-a1d5-8f3acce3bb7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWedge and Spacer Set
Version Model Number107106
Catalog Number107106
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 Numberfalse
Manufacturing Datetrue
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

Width18.6 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439111086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-19
Device Publish Date2017-08-02

On-Brand Devices [Wedge and Spacer Set]

008414391110862.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer
008414391146432.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR

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