FDA UDI
In Commercial Distribution
🇺🇸 United States
exGraft
DI: 00818136020225
·
Model: RGX163501
·
PECA LABS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- exGraft
- Primary DI
- 00818136020225
- Version / Model
- RGX163501
- Catalog Number
- RUX163501
- Company Name
- PECA LABS, INC.
- Labeler DUNS
- 078340058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 8e463e3a-ded6-4676-a4cd-ab35019639b3
Device Description
16mm ID x 35cm Length exGraft ePTFE Vascular Graft
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00818136021147 | GS1 | Shipper/Outer Box | 1 | In Commercial Distribution | |
| Primary | 00818136020225 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180957 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter | |
| Lumen/Inner Diameter | 16 | Millimeter |