TissueStat
TissueStat 2-0 PTFE Kit
1manufacturer
1catalogue number
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 | DuraStat, United States |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2024-02-05 |
| Record revised | 2024-09-30 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TIS-001 | Withdrawn |
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 |
|---|---|
| K231277 | 2023-11-09 |
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.