Premilene
Premilene 4/0 (1.5) 2X75CM 2XDRC18B Cvlp
3manufacturers in China registered for this device type
1,247catalogue 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 | B Braun Surgical SA |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Record published | 2015-08-19 |
| Record revised | 2024-05-08 (version 16) |
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 |
| Packaging | Carton of 30 |
| Sizes | Length 5 to 150 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B2090454 | Length 100.00 cm | 24 | In distribution |
| G0095841 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G2090814 | Length 45.00 cm | 12 | Withdrawn |
| C2095129 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X2090042 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| C2095029 | Length 60.00 cm | 36 | Withdrawn |
| G0095253 | Length 75.00 cm | 12 | Withdrawn |
| C2090537 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090945 | Thread Material : polypropylene | 36 | Withdrawn |
| G0095078 | Length 90.00 cm | 12 | Withdrawn |
| G0095882 | Thread Material : polypropylene | 12 | Withdrawn |
| G0095077 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C2090810 | Length 90.00 cm | 36 | Withdrawn |
| C2090321 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090909 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C2090849 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090458 | Thread Material : polypropylene | 36 | Withdrawn |
| G0090210 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C2090953 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090051 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090213 | Length 45.00 cm | 4 | Withdrawn |
| X2090745 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090724 | Length 75.00 cm | 4 | Withdrawn |
| C2095446 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090742 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| G0095858 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| X2090406 | Length 75.00 cm | 4 | Withdrawn |
| G2090920 | Length 90.00 cm | 12 | Withdrawn |
| G0090613 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C2090545 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| X2090976 | Length 90.00 cm | 4 | Withdrawn |
| X2090919 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C2095228 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090319 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0095030 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| X2090708 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090526 | Length 90.00 cm | 36 | Withdrawn |
| C2095175 | Thread Material : polypropylene | 36 | Withdrawn |
| G0090168 | Length 75.00 cm | 12 | Withdrawn |
| C2095790 | Thread Material : polypropylene | 36 | Withdrawn |
| G0095615 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090273 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C2095634 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090715 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090309 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090281 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C2095056 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090527 | Thread Material : polypropylene | 36 | Withdrawn |
| G0090194 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| G2090630 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095654 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090977 | Thread Material : polypropylene | 4 | Withdrawn |
| G0095751 | Length 90.00 cm | 12 | Withdrawn |
| C2090340 | Length 75.00 cm | 36 | Withdrawn |
| C2090561 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G2090609 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G0095234 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090800 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C2090555 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090657 | Length 45.00 cm | 36 | Withdrawn |
| C2095101 | Length 75.00 cm | 36 | Withdrawn |
| G0095232 | Length 90.00 cm | 12 | Withdrawn |
| C2090954 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0090651 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C2090098 | Thread Material : polypropylene | 36 | Withdrawn |
| C2095600 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| G0095224 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090241 | Thread Material : polypropylene | 36 | Withdrawn |
| G0090362 | Length 45.00 cm | 12 | Withdrawn |
| G2090327 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090581 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090716 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090047 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C2095110 | Thread Material : polypropylene | 36 | Withdrawn |
| C2095887 | Length 45.00 cm | 36 | Withdrawn |
| C2090257 | Thread Material : polypropylene | 36 | Withdrawn |
| G0095174 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| X2090255 | Thread Material : polypropylene | 4 | Withdrawn |
| G0090064 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090721 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C2095662 | Length 120.00 cm | 36 | Withdrawn |
| G2090466 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090219 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C2090050 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X2090501 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| X2090909 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| G0090644 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C2090944 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0090980 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C2090677 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C2090511 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090742 | Size of Thread (USP – Others) : 7/0 | 4 | Withdrawn |
| X2090741 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090308 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C2095208 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X2090620 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| C2095113 | Length 120.00 cm | 36 | Withdrawn |
| G0095986 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090151 | Length 75.00 cm | 36 | Withdrawn |
| G2090606 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| G0090770 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095290 | Length 75.00 cm | 36 | Withdrawn |
| C2090037 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090983 | Thread Material : polypropylene | 12 | Withdrawn |
| G2090215 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G2090612 | Length 45.00 cm | 12 | Withdrawn |
| G2090043 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090893 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C2090092 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0090373 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C2090865 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C2095130 | Thread Material : polypropylene | 36 | Withdrawn |
| G0095252 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| X2090902 | Thread Material : polypropylene | 4 | Withdrawn |
| G2090938 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| X2090236 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090656 | Length 45.00 cm | 36 | Withdrawn |
| C2090524 | Length 60.00 cm | 36 | Withdrawn |
| G0095984 | Length 90.00 cm | 12 | Withdrawn |
| G0090121 | Length 60.00 cm | 12 | Withdrawn |
| G0095795 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095477 | Length 60.00 cm | 36 | Withdrawn |
| G2090235 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C2095938 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C2090917 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C2095165 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0095903 | Thread Material : polypropylene | 12 | Withdrawn |
| G0095627 | Thread Material : polypropylene | 12 | Withdrawn |
| G0095191 | Length 75.00 cm | 12 | Withdrawn |
| C2090712 | Size of Thread (USP – Others) : 8/0 | 36 | Withdrawn |
| C2095946 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0095158 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C2095114 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090211 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C2090719 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0095261 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090846 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090188 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090715 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| X2090341 | Length 75.00 cm | 4 | Withdrawn |
| C2090101 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090717 | Thread Material : polypropylene | 36 | Withdrawn |
| G0095616 | Length 75.00 cm | 12 | Withdrawn |
| C2095091 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X2090533 | Length 75.00 cm | 4 | Withdrawn |
| X2090744 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090876 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0095942 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C2090964 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C2090542 | Length 75.00 cm | 36 | Withdrawn |
| C2095612 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090628 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090496 | Length 45.00 cm | 36 | Withdrawn |
| X2090221 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| X2090680 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090905 | Length 90.00 cm | 36 | Withdrawn |
| X2090006 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C2090697 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G2090580 | Thread Material : polypropylene | 12 | Withdrawn |
| G0095566 | Length 45.00 cm | 12 | Withdrawn |
| C2095495 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090235 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090206 | Length 45.00 cm | 36 | Withdrawn |
| G2090256 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| C2095045 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C2090030 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C2090029 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090270 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090016 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G0095472 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| G0090597 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095360 | Length 75.00 cm | 36 | Withdrawn |
| X2090531 | Length 75.00 cm | 4 | Withdrawn |
| X2090725 | Length 75.00 cm | 4 | Withdrawn |
| G0090611 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095173 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090750 | Length 90.00 cm | 4 | Withdrawn |
| G0095125 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095112 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090657 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090306 | Length 75.00 cm | 4 | Withdrawn |
| C2090004 | Length 75.00 cm | 36 | Withdrawn |
| X2090041 | Length 75.00 cm | 4 | Withdrawn |
| C2090676 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X2090521 | Length 75.00 cm | 4 | Withdrawn |
| G0095072 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C2095352 | Thread Material : polypropylene | 36 | Withdrawn |
| G0090781 | Length 10.00 cm | 12 | Withdrawn |
| C2095908 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0090783 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| X2090693 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| G2090246 | Thread Material : polypropylene | 12 | Withdrawn |
| X2090257 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090120 | Thread Material : polypropylene | 4 | Withdrawn |
| G0095176 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090116 | Thread Material : polypropylene | 36 | Withdrawn |
| C2095920 | Length 60.00 cm | 36 | Withdrawn |
| G0095561 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090594 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| C2090938 | Thread Material : polypropylene | 36 | Withdrawn |
| C2095297 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090763 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| X2090287 | Length 75.00 cm | 4 | Withdrawn |
| G2090581 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C2095613 | Length 45.00 cm | 36 | Withdrawn |
| C2090136 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C2095668 | Length 120.00 cm | 36 | Withdrawn |
| X2090903 | Thread Material : polypropylene | 4 | Withdrawn |
| C2095421 | Thread Material : polypropylene | 36 | Withdrawn |
| C2095779 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X2090785 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090035 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090681 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0090892 | Thread Material : polypropylene | 12 | Withdrawn |
| C2090153 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G2090050 | Length 75.00 cm | 12 | Withdrawn |
| C2095565 | Thread Material : polypropylene | 36 | Withdrawn |
| G2090264 | Length 45.00 cm | 12 | Withdrawn |
| X2090205 | Thread Material : polypropylene | 4 | Withdrawn |
| C2095837 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0095181 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090778 | Length 8.00 cm | 12 | Withdrawn |
| C2090809 | Thread Material : polypropylene | 36 | Withdrawn |
| C2090629 | Length 45.00 cm | 36 | Withdrawn |
| C2095064 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| G0095881 | Thread Material : polypropylene | 12 | Withdrawn |
| C2095906 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| X2090254 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090844 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0095890 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| X2090466 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090219 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090580 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| G0090216 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C2095266 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C2095932 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G2090629 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| X2090237 | Thread Material : polypropylene | 4 | Withdrawn |
| X2090100 | Thread Material : polypropylene | 4 | Withdrawn |
| C2090923 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0090636 | Length 45.00 cm | 12 | Withdrawn |
| C2090690 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090309 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| G2095958 | Thread Material : polypropylene | 12 | Withdrawn |
| G0090609 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C2090903 | Thread Material : polypropylene | 36 | Withdrawn |
| X2090780 | Size of Thread (USP – Others) : 8/0 | 4 | Withdrawn |
| C2095466 | Length 45.00 cm | 36 | Withdrawn |
| C2090053 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C2090553 | Length 45.00 cm | 36 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| 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 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| 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.