Monotex
36 catalogue numbers from T8001, listed by Riverpoint Medical LLC, United States, under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene. 1 manufacturer in China is registered for this product code.
1manufacturer
36catalogue numbers in this listing
1510(k) clearance
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 | Riverpoint Medical LLC, United States |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-13 |
| Record revised | 2023-06-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T8001 | In distribution | |
| T8101C | In distribution | |
| T8664C | In distribution | |
| T8409 | In distribution | |
| T8697 | In distribution | |
| T8204C | In distribution | |
| T8604C | In distribution | |
| T0618 | In distribution | |
| T8000C | In distribution | |
| T8204 | In distribution | |
| T8501 | In distribution | |
| T8209 | In distribution | |
| T6K02 | In distribution | |
| T8698C | In distribution | |
| T8682 | In distribution | |
| T8000 | In distribution | |
| T8209C | In distribution | |
| T8695C | In distribution | |
| T8624 | In distribution | |
| T8604 | In distribution | |
| T2513 | In distribution | |
| T8665C | In distribution | |
| T8400 | In distribution | |
| T8664 | In distribution | |
| T8695 | In distribution | |
| T8682C | In distribution | |
| T0518 | In distribution | |
| T8403 | In distribution | |
| T8001C | In distribution | |
| T2509 | In distribution | |
| T8698 | In distribution | |
| T8500 | In distribution | |
| T8665 | In distribution | |
| T8402 | In distribution | |
| T8636 | In distribution | |
| T8623 | 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 |
| 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 |
| Golnit PTFE Suture | Golnit Sutures | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140415 | 2014-03-26 |
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.