Fiducial Markers MTNW887852

GUDID 00841439109762

Sterile (1.0 x 5mm) CyberMark soft tissue gold markers

MEDTEC, INC.

Imaging lesion localization marker, implantable
Primary Device ID00841439109762
NIH Device Record Key897b24c5-bf44-417b-bd9a-a18a05ec438d
Commercial Distribution Discontinuation2019-05-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFiducial Markers
Version Model NumberMTNW887852
Catalog NumberMTNW887852
Company DUNS103977526
Company NameMEDTEC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com
Phone+1(712)737-8688
Emailradiotherapy.complaints@civcort.com

Device Dimensions

Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch
Length0.2 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841439109762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


[00841439109762]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-20
Device Publish Date2017-08-02

On-Brand Devices [Fiducial Markers]

00841439109762Sterile (1.0 x 5mm) CyberMark soft tissue gold markers
00841439109793Sterile (1.0 x 5mm) CyberMark™ soft tissue gold marker [4]
00841439109786Sterile (1.0 x 5mm) CyberMark™ soft tissue gold marker
00841439109687Sterile (1.2 x 3mm) soft tissue gold markers
00841439109670Sterile (1.2 x 3mm) soft tissue gold marker [3]
00841439109656Sterile (0.9 x 3mm) soft tissue gold marker [3]
00841439109649Sterile (0.8 x 3mm) soft tissue gold marker [3]
00841439109632Sterile (2mm spheres) bone gold marker [3]

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