FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoForce
DI: 00860014060601
·
Model: EFORCE-100
·
Phraxis Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoForce
- Primary DI
- 00860014060601
- Version / Model
- EFORCE-100
- Company Name
- Phraxis Inc.
- Labeler DUNS
- 825429017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-24
- Public Version
- 3
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- 623455cb-bfcb-4ef7-a1d5-ffac688142e2
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SEQ | Covered Stent Vascular Connector, Hemodialysis Access Circuit | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35281 | Synthetic vascular graft, non-medicated | An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014060601 | GS1 |
Customer Contacts
- Phone
- 8043574772
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240004 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 66 | Millimeter |