Bite Cup MTHF135

GUDID 10841439104245

For use with trUpoint ARCH™

MEDTEC, INC.

Stereotactic radiosurgical/radiotherapy arch head frame
Primary Device ID10841439104245
NIH Device Record Keyfbb7361a-97ad-463b-8c95-1c414cc34f2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBite Cup
Version Model NumberMTHF135
Catalog NumberMTHF135
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Length3.2 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439104248 [Package]
Package: [12 Units]
In Commercial Distribution
GS110841439104245 [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 Number8
Public Version Date2020-04-01
Device Publish Date2017-08-02

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