Unify PTFE Surgical Sutures
PTFE Sutures, Non-absorbable, 2-0, monofilament, 36mm 1/2 circle Taper point, 30"
1manufacturer
13catalogue numbers in this listing
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 | Applied Dental, Inc. |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| 510(k) | K170842 |
| Record published | 2020-08-06 |
| Record revised | 2023-06-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, case of 100, carton of 100 |
| Distribution end date | 2023-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XL-F230T36 | In distribution | |
| S-F518R13 | In distribution | |
| S-F618R13 | In distribution | |
| M-F218R19 | In distribution | |
| M-F518R16 | In distribution | |
| M-F418R19 | In distribution | |
| S-F418R13 | In distribution | |
| M-F318R19 | In distribution | |
| XXL-F230K60 | In distribution | |
| M-F418R16 | In distribution | |
| M-F318R16 | In distribution | |
| S-F418T13 | Withdrawn | |
| XXL-F330K50 | Withdrawn |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 |
| 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
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.