Marker Placement Needle MTNW887358

GUDID 00841439109588

18GA ETW x 20cm

MEDTEC, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID00841439109588
NIH Device Record Key2eb85ca7-d73c-4e4a-a780-27a503aa19cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMarker Placement Needle
Version Model NumberMTNW887358
Catalog NumberMTNW887358
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 Kitfalse
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

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
GS100841439109588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


[00841439109588]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-23
Device Publish Date2017-08-02

On-Brand Devices [Marker Placement Needle]

0084143910958818GA ETW x 20cm
0084143910957117GA ETW x 20cm

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