Stratafix Spiral
2RB-1 2-0 U MND 16X16 13MM LDR
4manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Record published | 2015-10-22 |
| Record revised | 2024-12-25 (version 6) |
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 | Box of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SXMD1B406 | 0 USP | In distribution |
| SXMD2B402 | 2-0 USP | In distribution |
| SXMD2B410 | 2-0 USP | In distribution |
| SXMD2B408 | 2-0 USP | In distribution |
| SXMD1B101 | 2-0 USP | In distribution |
| SXMD2B413 | 3-0 USP | In distribution |
| SXMD1B405 | 2-0 USP | In distribution |
| SXMD2B407 | 3-0 USP | In distribution |
| SXMD1B409 | 1 USP | In distribution |
| SXMD2B405 | 3-0 USP | In distribution |
| SXMD2B403 | 3-0 USP | In distribution |
| SXMD2B412 | 2-0 USP | In distribution |
| SXMD1B404 | 0 USP | In distribution |
| SXMD2B409 | 3-0 USP | In distribution |
| SXMD1B403 | 2-0 USP | In distribution |
| SXMD1B100 | 2-0 USP | In distribution |
| SXMD1B407 | 2-0 USP | In distribution |
| SXMD1B402 | 3-0 USP | In distribution |
| SXMD2B401 | 0 USP | In distribution |
| SXMD1B103 | 2-0 USP | In distribution |
| SXMD2B400 | 0 USP | In distribution |
| SXMD2B150 | 3-0 USP | In distribution |
| SXMD2B404 | 2-0 USP | In distribution |
| SXMD1B105 | 3-0 USP | In distribution |
| SXMD2B406 | 2-0 USP | In distribution |
| SXMD1B408 | 0 USP | In distribution |
| SXMD1B106 | 3-0 USP | In distribution |
| SXMD1B104 | 2-0 USP | In distribution |
| SXMD1B102 | 0 USP | In distribution |
| SXMD2B411 | 2-0 USP | In distribution |
| SXMD2B414 | 0 USP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ethicon, Inc. | UDI-DI | 2022-09-20 | Class II | Under Investigation by firm | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair | 2,280 eaches |
| Ethicon, Inc. | UDI-DI | 2022-03-24 | Class II | Employee error | Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. | 2808 (all OUS) |
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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, 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.