Thermoplastic Frame MTPLHA01

GUDID 00841439107010

Reloadable non-sterile thermoplastic frame set for use with HipFix®

MEDTEC, INC.

Patient positioning thermoplastic mould material
Primary Device ID00841439107010
NIH Device Record Keya164af8c-3fe8-47f7-a68b-0fce95019a9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermoplastic Frame
Version Model NumberMTPLHA01
Catalog NumberMTPLHA01
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

Width2.5 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439107010 [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 Number4
Public Version Date2019-05-30
Device Publish Date2017-09-22

On-Brand Devices [Thermoplastic Frame]

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00841439107133Reloadable non-sterile thermoplastic frame set
00841439107010Reloadable non-sterile thermoplastic frame set for use with HipFix®
00841439106518For use with lateral baseplate
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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