AccessGUDID - DEVICE: FOGARTY (00690103043549)

GUDID

Device Identifier (DI) Information

Brand Name: FOGARTY
Version or Model: 12TLW806F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12TLW806F
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103043549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 6F 80CM

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58174	Thrombectomy balloon catheter	A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	CATHETER, EMBOLECTOMY
KRA	Catheter, Continuous Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240078	000
K892410	000

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 IN A COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: CATHETER FRENCH SIZE: 6F (2.0MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 7F (2.3MM)

Device Record Status

Public Device Record Key: 0517003d-4a07-4680-afe0-94947665b440
Public Version Date: October 29, 2024
Public Version Number: 5
DI Record Publish Date: September 03, 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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