Ultrabraid
ULTRABRAID No.2 WHITE SUTURE AND NEEDLE ASSEMBLY, 38 INCH, 10 PER BOX, STERILE
6manufacturers in China registered for this device type
9catalogue numbers in this listing
11510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K041216 |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 9) |
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 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7211081 | In distribution | |
| 72200887 | In distribution | |
| 72204328 | In distribution | |
| 72204327 | In distribution | |
| 7211080 | In distribution | |
| 7210914 | In distribution | |
| 72202965 | In distribution | |
| 7210915 | In distribution | |
| 72200886 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203393 | 2021-02-01 |
| K132079 | 2013-12-05 |
| K132357 | 2013-10-30 |
| K121861 | 2012-10-18 |
| K092508 | 2010-01-28 |
| K072322 | 2007-09-18 |
| K052652 | 2005-10-21 |
| K041216 | 2004-06-07 |
| K040789 | 2004-06-04 |
| K984550 | 1999-03-01 |
| K980155 | 1998-04-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-04-30 | Class II | Package design/selection | Sterility of device maybe compromised | 202,279 units | 2017-09-19 |
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 621 units | 2012-05-09 |
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 53 units | 2012-05-09 |
| 2010-10-14 | Not classified | Device Design | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 130 units | 2012-05-09 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | 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.