AccessGUDID - DEVICE: EndoForce (00860014060601)

GUDID

Device Identifier (DI) Information

Brand Name: EndoForce
Version or Model: EFORCE-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Phraxis Inc.

Primary DI Number: 00860014060601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825429017 *Terms of Use

Device Description: The EndoForce™ Connector for Endovascular Venous Anastomosis (herein referred to as the EndoForce™ System) includes an implantable component, the EndoForce™ Connector and a delivery system, EndoForce™ Connector Delivery System. The EndoForce Connector™ is a venous anastomosis implant used in conjunction with a 6 mm inner diameter expanded polytetrafluoroethylene (ePTFE) arteriovenous graft (not provided). The graft is sutured to the artery using a conventional anastomosis. The graft, and not the EndoForce™ Connector, is to be used for vascular access during hemodialysis in patients with end stage renal disease. The EndoForce™ Connector is provided pre-loaded within the EndoForce™ Connector Delivery System.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
SEQ	Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240004	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Stent Length: 66 Millimeter

Device Record Status

Public Device Record Key: 623455cb-bfcb-4ef7-a1d5-ffac688142e2
Public Version Date: July 02, 2025
Public Version Number: 1
DI Record Publish Date: June 24, 2025