DEVICE: microTargeting™ Insertion Tube (10873263007645)

Device Identifier (DI) Information

microTargeting™ Insertion Tube
FC7140LI-00764
In Commercial Distribution
FC7140LI
FHC, INC.
10873263007645
GS1

5
108179458 *Terms of Use
microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive.
CLOSE

Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62753 Intracerebral cannula, nonimplantable, single-use
A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological stereotaxic Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011775 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 1.83 Millimeter
Length: 225.35 Millimeter
Lumen/Inner Diameter: 1.6 Millimeter
CLOSE

Device Record Status

86e8604d-f523-4bd5-923e-c70c8f7f0ada
January 06, 2020
1
December 27, 2019
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00873263007648 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)326-2905
fhcinc@fh-co.com
CLOSE