exGraft
GUDID 00818136020881
24mm x 15cm exGraft ePTFE Vascular Graft
PECA LABS, INC.
Synthetic vascular graft| Primary Device ID | 00818136020881 |
| NIH Device Record Key | 217b0494-0e31-4ea9-b280-94e9b51534eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | exGraft |
| Version Model Number | RGX241501 |
| Company DUNS | 078340058 |
| Company Name | PECA LABS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
| Length | 15 Centimeter |
| Lumen/Inner Diameter | 24 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818136020362 [Primary] |
| GS1 | 00818136020881 [Package] Contains: 00818136020362 Package: Outer/Shipper Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202471
FDA Product Code
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-09 |
| Device Publish Date | 2021-02-01 |
On-Brand Devices [exGraft]
| 00818136021024 | 10mm ID x 35cm length exGraft Carbon ePTFE Vascular Graft |
| 00818136021147 | 16mm ID x 35cm Length exGraft ePTFE Vascular Graft |
| 00818136020584 | 8mm ID X 35cm Length exGraft ePTFE Vascular Graft |
| 00818136020546 | 6mm ID X 35cm Length exGraft ePTFE Vascular Graft |
| 00818136020980 | 8mm ID X 35cm Length exGraft Carbon ePTFE Vascular Graft |
| 00818136020621 | 10mm ID x 35cm length exGraft ePTFE Vascular Graft |
| 00818136023257 | 19mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136023226 | 13mm ID x 35cm Length exGraft ePTFE Vascular Graft |
| 00818136022786 | 5mm ID x 35cm Length exGraft ePTFE Vascular Graft |
| 00818136022748 | 4mm ID x 35cm Length exGraft ePTFE vascular graft |
| 00818136022700 | 3.5mm ID x 35cm Length exGraft ePTFE vascular graft |
| 00818136022663 | 3mm ID x 35cm Length exGraft ePTFE Vascular Graft |
| 00818136020461 | 8mm ID X 35cm Length exGraft Carbon ePTFE Vascular Graft |
| 00818136020775 | 18mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136020706 | 14mm ID x 35cm L exGraft ePTFE Vascular Graft |
| 00818136020669 | 12mm ID x 35cm L exGraft ePTFE Vascular Graft |
| 00818136020881 | 24mm x 15cm exGraft ePTFE Vascular Graft |
| 00818136020850 | 22mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136020812 | 20mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136023240 | 19mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136023219 | 13mm ID x 25cm Length exGraft ePTFE Vascular Graft |
| 00818136023202 | 13mm ID x 15cm Length exGraft ePTFE Vascular Graft |
| 00818136022373 | 5mm ID x 25cm Length exGraft ePTFE Vascular Graft |
| 00818136022762 | 5mm ID x 15cm Length exGraft ePTFE Vascular Graft |
| 00818136022731 | 4mm ID x 25cm Length exGraft ePTFE vascular graft |
| 00818136022724 | 4mm ID x 15cm Length exGraft ePTFE vascular graft |
| 00818136022298 | 3.5mm ID x 25cm Length exGraft ePTFE vascular graft |
| 00818136022687 | 3.5mm ID x 15cm Length exGraft ePTFE vascular graft |
| 00818136022656 | 3mm ID x 25cm Length exGraft ePTFE Vascular Graft |
| 00818136022243 | 3mm ID x 15cm Length exGraft ePTFE Vascular Graft |
| 00818136020843 | 22mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136020805 | 20mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136020768 | 18mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136020737 | 16mm ID x 25cm Length exGraft ePTFE Vascular Graft |
| 00818136020720 | 16mm ID x 15cm Length exGraft ePTFE Vascular Graft |
| 00818136020690 | 14mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136020683 | 14mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136020652 | 12mm ID x 25cm L exGraft ePTFE Vascular Graft |
| 00818136020645 | 12mm ID x 15cm L exGraft ePTFE Vascular Graft |
| 00818136020614 | 10mm ID x 25cm length exGraft ePTFE Vascular Graft |
| 00818136020607 | 10mm ID x 15cm length exGraft ePTFE Vascular Graft |
| 00818136020577 | 8mm ID X 25cm Length exGraft ePTFE Vascular Graft |
| 00818136020560 | 8mm ID X 15cm Length exGraft ePTFE Vascular Graft |
| 00818136020539 | 6mm ID X 25cm Length exGraft ePTFE Vascular Graft |
| 00818136020003 | 6mm ID X 15cm Length exGraft ePTFE Vascular Graft |
Trademark Results [exGraft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXGRAFT 87186606 5487334 Live/Registered |
PECA Labs 2016-09-28 |
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