Sterile PTFE Surgical Suture
3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 6/0 EXTRA CUTTING 12MM 3/8 CIRCLE REVERSE CUTTING
1manufacturer
45catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Omnia Medical, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K180630 |
| Record published | 2016-11-29 |
| Record revised | 2025-04-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP AWAY FROM SUNLIGHT AND KEEP DRY |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 32.Z3161.00 | 12 | In distribution | |
| 32.Z4409.00 | 12 | In distribution | |
| PSNPTFE12 | 12 | In distribution | |
| 32.Z4404.00 | 12 | In distribution | |
| 32.Z3250.00 | 12 | In distribution | |
| 32.Z4406.00 | 12 | In distribution | |
| 32.Z4405.00 | 12 | In distribution | |
| PSNPTFE9SPL | 3 | In distribution | |
| 32.Z4401.00 | 12 | In distribution | |
| PSNPTFE5SPL | 3 | In distribution | |
| PSNPTFE6 | 12 | In distribution | |
| PSNPTFE11SPL | 3 | In distribution | |
| PSNPTFE3 | 12 | In distribution | |
| 32.Z3270.00 | 12 | In distribution | |
| 32.Z3252.00 | 12 | In distribution | |
| PSNPTFE5 | 12 | In distribution | |
| PSNPTFE12SPL | 3 | In distribution | |
| 32.Z3260.00 | 12 | In distribution | |
| 32.Z4403.00 | 12 | In distribution | |
| PSNPTFE10 | 12 | In distribution | |
| 32.Z4402.00 | 12 | In distribution | |
| PSNPTFE3SPL | 3 | In distribution | |
| 32.Z3151.00 | 12 | In distribution | |
| PSNPTFE1SPL | 3 | In distribution | |
| 32.Z3150.00 | 12 | In distribution | |
| 32.Z3130.00 | 12 | In distribution | |
| PSNPTFE10SPL | 3 | In distribution | |
| PSNPTFE2SPL | 3 | In distribution | |
| 32.Z4407.00 | 12 | In distribution | |
| 32.Z4408.00 | 12 | In distribution | |
| PSNPTFE9 | 12 | In distribution | |
| PSNPTFE4 | 12 | In distribution | |
| PSNPTFE8 | 12 | In distribution | |
| PSNPTFE7 | 12 | In distribution | |
| PSNPTFE8SPL | 3 | In distribution | |
| PSNPTFE7SPL | 3 | In distribution | |
| PSNPTFE4SPL | 3 | In distribution | |
| 32.Z4400.00 | 12 | In distribution | |
| 32.Z3240.00 | 12 | In distribution | |
| PSNPTFE1 | 12 | In distribution | |
| PSNPTFE6SPL | 3 | In distribution | |
| 32.Z3160.00 | 12 | In distribution | |
| 32.Z3141.00 | 12 | In distribution | |
| PSNPTFE2 | 12 | In distribution | |
| PSNPTFE11 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demetech PTFE | Demetech Corp. | 201 |
| Biotex | Purgo Biologics Inc. | 60 |
| 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 |
| Golnit PTFE Suture | Golnit Sutures | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180630 | 2018-04-06 |
| K132464 | 2014-02-12 |
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.