AccessGUDID - DEVICE: FiberNet (08033477034294)

GUDID

Device Identifier (DI) Information

Brand Name: FiberNet
Version or Model: FBC500600190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 08033477034294
Issuing Agency: GS1
Commercial Distribution End Date: October 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: Cath FBC500600190 FBC SW 5.0-6.0 UL1900

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44841	Embolic protection filtering guidewire	A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTE	Temporary Carotid Catheter for Embolic Capture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at controlled room temperature, in a dry place. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.0-6.0 MM Recommended Vessel Diameter
Length: 190.0 Centimeter

Device Record Status

Public Device Record Key: 6f1e560c-3491-43e3-b480-7585416c51ea
Public Version Date: April 09, 2019
Public Version Number: 4
DI Record Publish Date: May 08, 2016

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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