ZiFix Traverse RT-4558CB04

GUDID 00841439114841

ZiFix Traverse with ONEClamp

MEDTEC, INC.

Radiological whole-body positioner
Primary Device ID00841439114841
NIH Device Record Key2f16fae1-bd4f-461a-8ca2-dd8943f5399b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZiFix Traverse
Version Model NumberRT-4558CB04
Catalog NumberRT-4558CB04
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com
Phone+1 712-737-8688
Emailregulatory@cqmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439114841 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-22
Device Publish Date2025-09-12

Devices Manufactured by MEDTEC, INC.

00841439114650 - Pronumbra2025-09-22 Pronumbra Helping Hand, Left
00841439114674 - Pronumbra2025-09-22 Pronumbra Helping Hand, Right
00841439114681 - Pronumbra2025-09-22 Pronumbra 130cm kVue
00841439114698 - Pronumbra2025-09-22 Pronumbra Neck Support, 40mm
00841439114704 - Pronumbra2025-09-22 Pronumbra Neck Support, 50mm
00841439114711 - Pronumbra2025-09-22 Pronumbra Neck Support, 65mm
00841439114728 - Pronumbra2025-09-22 Pronumbra Shoulder Adapter
00841439114841 - ZiFix Traverse2025-09-22ZiFix Traverse with ONEClamp
00841439114841 - ZiFix Traverse2025-09-22 ZiFix Traverse with ONEClamp

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