Fiducial Marker Kit MTNW887810

GUDID 00841439109663

Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.2 x 3mm) soft tissue gold marker (1), 10mm spacer (1), (1.2 x 3mm) soft tissue gold marker (1)

MEDTEC, INC.

Imaging lesion localization marker, implantable
Primary Device ID00841439109663
NIH Device Record Key61cae32c-772a-4b20-85ea-c8033755ed94
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiducial Marker Kit
Version Model NumberMTNW887810
Catalog NumberMTNW887810
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
GS100841439109663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

Ethylene Oxide


[00841439109663]

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 [Fiducial Marker Kit]

00841439109861Sterile placement needles (18GA ETW x 20cm) with bone wax and (0.9 x 3mm) soft tissue gold marke
00841439109854Sterile placement needles (18GA ETW x 20cm) with bone wax and (0.9 x 3mm) soft tissue gold marke
00841439109847Sterile placement needle (18GA ETW x 12cm) with bone wax and (0.9 x 3mm) soft tissue gold marker
00841439109830Sterile placement needles (18GA ETW x 12cm) with bone wax and (0.9 x 3mm) soft tissue gold marke
00841439109816Sterile gold suture marker (2.0mm) attached with polydioxanone monofilament synthetic absorbable
00841439109809Sterile placement needles (14GA ETW x 20cm) with bone wax and (1.6 x 3mm) soft tissue gold marke
00841439109779Sterile placement needles (18GA ETW x 20cm) with bone wax and (1 x 5mm) CyberMark™ soft tissue
00841439109755Sterile palcement needle (18GA ETW x 20cm) with bone wax and (1 x 5mm) CyberMark™ soft tissue
00841439109748Sterile placement needles (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marke
00841439109731Sterile placement needle (17GA ETW x 30cm) with bone wax and (1.2 x 3mm) soft tissue gold marker
00841439109724Sterile placement needle (17GA ETW x 30cm) with bone wax and (1.2 x 3mm) soft tissue gold marker
00841439109717Sterile placement needles (17GA ETW x 30cm) with bone wax and (1.2 x 3mm) soft tissue gold marke
00841439109700Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker
00841439109694Sterile placement needles (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marke
00841439109663Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.2 x 3mm) soft tissue gold marker (1

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