Thermoplastic Frame MTRFH2

GUDID 00841439107126

Reloadable non-sterile thermoplastic frame set

MEDTEC, INC.

Radiological breast positioner, non-wearable
Primary Device ID00841439107126
NIH Device Record Key2fcbfc63-5e23-4f37-8822-88d2db5f8c97
Commercial Distribution Discontinuation2019-03-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameThermoplastic Frame
Version Model NumberMTRFH2
Catalog NumberMTRFH2
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 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

Length44.5 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439107126 [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 Date2019-03-20
Device Publish Date2017-08-02

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