LS-5™ ePTFE Quick Load®
LS-5 ePTFE QUICK LOAD is a nonabsorbable surgical suture used to bring soft tissues together, including in cardiovascular surgery. It is a monofilament made from expanded…
LS-5 ePTFE QUICK LOAD is a nonabsorbable surgical suture used to bring soft tissues together, including in cardiovascular surgery. It is a monofilament made from expanded polytetrafluoroethylene and is supplied sterile for use in one patient.
A short stainless steel ferrule is attached to each end of the suture to interface with compatible LSI SOLUTIONS suture placement devices. A customized tray holds the suture and incorporates a release feature for loading it into the placement device.
Listed Item
LS-5™ ePTFE QUICK LOAD® SUTURE, MONOFILAMENT, NON-ABSORBABLE, 38″, 2 FERRULES
Suture Handling
A detachable clear tube helps keep the suture from tangling. The suture is undyed and contains no additives. The two ferrules serve as the connection to the placement instrument during loading.
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | LSI Solutions Inc., United States |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Manufacturer |
| 510(k) | K163639 |
| Record published | 2020-03-13 |
| Record revised | 2023-08-03 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner pack of 12 |
| Sizes | Length 38 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 022295 | Length 38 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demetech PTFE | Demetech Corp. | 201 |
| Biotex | Purgo Biologics Inc. | 60 |
| Sterile PTFE Surgical Suture | Omnia Medical | 45 |
| Monotex | Riverpoint Medical LLC | 36 |
| Cytoplast™ PTFE Suture | Osteogenics Biomedical, Inc. | 34 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 24 |
| Cytosurg | Riverpoint Medical LLC | 18 |
| Unify PTFE Surgical Sutures | Applied Dental, Inc. | 13 |
| Klosure | Riverpoint Medical LLC | 10 |
| Gibson | Benco Dental Supply Co. | 9 |
| Maxima | Henry Schein, Inc. | 9 |
| Ptfe | Riverpoint Medical LLC | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163639 | 2017-06-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.