Atramat
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 7-0 EP 0.5, 60 CM DOUBLE NEEDLE CVSVE-9.3 CARDIOVASCULAR SUPRAGLYDE TAPER POINT (Non Reflective Dark Needle) 9.3 MM 3/8 CIRCLE POLIPROPILENO…
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 7-0 EP 0.5, 60 CM DOUBLE NEEDLE CVSVE-9.3 CARDIOVASCULAR SUPRAGLYDE TAPER POINT (Non Reflective Dark Needle) 9.3 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 7-0, 60 CM DOBLE AGUJA CVSVE-9.3 CARDIOVASCULAR AHUSADA SUPRAGLYDE (ANTIRREFLEJANTE NEGRA) 9.3 MM 3/8 CIRCULO
3manufacturers in China registered for this device type
140catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Internacional Farmacéutica S.A DE C.V, Mexico |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| 510(k) | K911189 |
| Record published | 2018-07-06 |
| Record revised | 2023-06-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 65 % RH |
| Packaging | Dozen of 12, box with 24 packs of 24 |
| Sizes | Length 6.5 to 75 mm; length 25 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| POLIPROPILENO | Length 8 mm | In distribution |
| POLYPROPILENE | Length 13 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 25 µm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLIPROPILENO | Length 9 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLYPROPILENE | Length 13 mm | In distribution |
| POLIPROPILENO | Length 37 mm | In distribution |
| POLIPROPILENO | Length 6.5 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLYPROPILENE | Length 13 mm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLIPROPILENO | Length 40 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 25 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 60 mm | In distribution |
| POLYPROPILENE | Length 26 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 36 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 20 mm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLIPROPILENO | Length 30 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 37 mm | In distribution |
| POLYPROPILENE | Length 26 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 60 mm | In distribution |
| POLIPROPILENO | Length 11 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 11 mm | In distribution |
| POLIPROPILENO | Length 40 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLYPROPILENE | Length 24 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 30 mm | In distribution |
| POLYPROPILENE | Length 12 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 40 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 20 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLYPROPILENE | Length 12 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 37 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 6.5 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLYPROPILENE | Length 13 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 37 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 30 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 60 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLIPROPILENO | Length 75 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLYPROPILENE | Length 24 mm | In distribution |
| POLIPROPILENO | Length 60 mm | In distribution |
| POLIPROPILENO | Length 36 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 37 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 40 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLYPROPILENE | Length 12 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLIPROPILENO | USP 0 | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLYPROPILENE | Length 10 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 8 mm | In distribution |
| POLIPROPILENO | Length 36 mm | In distribution |
| POLYPROPILENE | Length 19 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 60 mm | In distribution |
| POLIPROPILENO | Length 9.3 mm | In distribution |
| POLIPROPILENO | Length 16 mm | In distribution |
| POLIPROPILENO | Length 24 mm | In distribution |
| POLIPROPILENO | Length 25 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 19 mm | In distribution |
| POLIPROPILENO | Length 13 mm | In distribution |
| POLIPROPILENO | Length 26 mm | In distribution |
| POLIPROPILENO | Length 10 mm | In distribution |
| POLYPROPILENE | Length 30 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLIPROPILENO | Length 17 mm | In distribution |
| POLYPROPILENE | Length 19 mm | In distribution |
| POLYPROPILENE | Length 17 mm | In distribution |
| POLIPROPILENO | Length 36 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Prolene | Ethicon, Inc. | 765 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro II | Covidien LP | 254 |
| Surgipro ll | Covidien LP | 152 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
| Gore-TEX Suture | W. L. Gore & Associates, Inc. | 113 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. |
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.