Thermoplastic Frame MTAPUR1

GUDID 00841439103814

Reloadable Uni-frame® base

MEDTEC, INC.

Indexed-immobilization patient positioning system
Primary Device ID00841439103814
NIH Device Record Key70c1cb5d-5488-412a-b7ed-4a78bfcf856e
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoplastic Frame
Version Model NumberMTAPUR1
Catalog NumberMTAPUR1
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

Length10.3 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439103814 [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 Date2019-05-30
Device Publish Date2017-09-25

On-Brand Devices [Thermoplastic Frame]

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00841439104118Reloadable Type-S™ frame with Safe-T pins (5)
00841439102008Reloadable pediatric Type-S™ frame
00841439107744Stereotactic frame
00841439107126Reloadable non-sterile thermoplastic frame set

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