Biotex
60 catalogue numbers from BT401655, listed by Purgo Biologics Inc., South Korea, under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene. 1 manufacturer in China is registered for this product code.
1manufacturer
60catalogue 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 | Purgo Biologics Inc., South Korea |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Manufacturer |
| 510(k) | K180992 |
| Record published | 2019-07-24 |
| Record revised | 2023-06-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT401655 | In distribution | |
| BTP4019D | In distribution | |
| BT5019 | In distribution | |
| BT301655 | In distribution | |
| BT401935D | In distribution | |
| BT301635D | In distribution | |
| BT501635 | In distribution | |
| BT501335D | In distribution | |
| BT4016 | In distribution | |
| BT5016 | In distribution | |
| BTP401335 | In distribution | |
| BT301655D | In distribution | |
| BT501335 | In distribution | |
| BTP301335D | In distribution | |
| BT4013 | In distribution | |
| BT5013 | In distribution | |
| BTP3013 | In distribution | |
| BTP401335D | In distribution | |
| BT401955D | In distribution | |
| BT401335D | In distribution | |
| BT301335D | In distribution | |
| BT401635 | In distribution | |
| BT301335 | In distribution | |
| BT4013D | In distribution | |
| BT401635D | In distribution | |
| BT3019D | In distribution | |
| BT4019D | In distribution | |
| BT3019 | In distribution | |
| BT401655D | In distribution | |
| BT401355D | In distribution | |
| BTP4019 | In distribution | |
| BTP301335 | In distribution | |
| BT4016D | In distribution | |
| BT501655 | In distribution | |
| BTP3013D | In distribution | |
| BT3013 | In distribution | |
| BT301955D | In distribution | |
| BT501935D | In distribution | |
| BT5019D | In distribution | |
| BT501935 | In distribution | |
| BT501635D | In distribution | |
| BT401935 | In distribution | |
| BT501655D | In distribution | |
| BT401355 | In distribution | |
| BT3016D | In distribution | |
| BT5013D | In distribution | |
| BT501355D | In distribution | |
| BT3016 | In distribution | |
| BT301935 | In distribution | |
| BT401335 | In distribution | |
| BT3013D | In distribution | |
| BT301935D | In distribution | |
| BT501355 | In distribution | |
| BT4019 | In distribution | |
| BT301635 | In distribution | |
| BT301955 | In distribution | |
| BTP4013D | In distribution | |
| BT5016D | In distribution | |
| BT401955 | In distribution | |
| BTP4013 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demetech PTFE | Demetech Corp. | 201 |
| 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 |
| Golnit PTFE Suture | Golnit Sutures | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180992 | 2019-07-16 |
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.