Visorb
91 catalogue numbers from 845A, listed by C P Medical Inc., under Suture, Absorbable, Synthetic, Polyglycolic Acid. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
91catalogue numbers in this listing
2recalls on this code
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 | C P Medical Inc. |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Record published | 2015-09-24 |
| Record revised | 2018-12-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 845A | In distribution | |
| 346A | In distribution | |
| 467A | In distribution | |
| 416A | In distribution | |
| 586A | In distribution | |
| 398A | In distribution | |
| 421A | In distribution | |
| 391A | In distribution | |
| 904A | In distribution | |
| 490A | In distribution | |
| 513A | In distribution | |
| 503A | In distribution | |
| 464A | In distribution | |
| 281A | In distribution | |
| 589A | In distribution | |
| 338A | In distribution | |
| 506A | In distribution | |
| 334A | In distribution | |
| 351A | In distribution | |
| 341A | In distribution | |
| 315A | In distribution | |
| 463A | In distribution | |
| 327A | In distribution | |
| 422A | In distribution | |
| 310A | In distribution | |
| 468A | In distribution | |
| 352A | In distribution | |
| 339A | In distribution | |
| 452A | In distribution | |
| 602A | In distribution | |
| 340A | In distribution | |
| 466A | In distribution | |
| 280A | In distribution | |
| 1093A | In distribution | |
| 317A | In distribution | |
| 266A | In distribution | |
| 328A | In distribution | |
| 423A | In distribution | |
| 492A | In distribution | |
| 495A | In distribution | |
| 494A | In distribution | |
| 504A | In distribution | |
| 181A | In distribution | |
| U386A | In distribution | |
| 1092A | In distribution | |
| 1094A | In distribution | |
| 282A | In distribution | |
| 180A | In distribution | |
| 345A | In distribution | |
| 396A | In distribution | |
| 500A | In distribution | |
| 354A | In distribution | |
| 535A | In distribution | |
| 935A | In distribution | |
| 333A | In distribution | |
| 417A | In distribution | |
| 507A | In distribution | |
| 392A | In distribution | |
| 269A | In distribution | |
| 603A | In distribution | |
| 303A | In distribution | |
| 332A | In distribution | |
| 427A | In distribution | |
| 195A | In distribution | |
| 311A | In distribution | |
| 397A | In distribution | |
| 316A | In distribution | |
| 905A | In distribution | |
| 489A | In distribution | |
| 497A | In distribution | |
| 946A | In distribution | |
| 945A | In distribution | |
| U385A | In distribution | |
| 453A | In distribution | |
| 426A | In distribution | |
| 259A | In distribution | |
| 393A | In distribution | |
| 496A | In distribution | |
| 428A | In distribution | |
| 683A | In distribution | |
| 364A | In distribution | |
| 336A | In distribution | |
| 587A | In distribution | |
| 353A | In distribution | |
| 493A | In distribution | |
| 936A | In distribution | |
| 834A | In distribution | |
| 385A | In distribution | |
| 260A | In distribution | |
| 443A | In distribution | |
| 386A | 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-01-02 | Not classified | Nonconforming Material/Component | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. | 13632 sutures | 2011-12-13 |
| 2007-04-03 | Not classified | Other | Potential for sterility of product to be compromised. Suture package seals incomplete or missing. | 13,596 suture packets | 2008-08-01 |
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.