Reli®
REDICAPRONE-25 Monofilament Poliglecaprone 25 Undyed Braided 4-0 YPS-2 18"
4manufacturers in China registered for this device type
101catalogue 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 | Myco Medical Supplies, Inc., United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| 510(k) | K172659 |
| Record published | 2019-05-13 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Recommended to be stored below 86°F (30°C), away from moisture and direct heat. |
| Packaging | Inner carton of 12, case of 30, 30 of 30 |
| Sizes | Length 18 to 36 in; height 18 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V340-M | Length 30 in | In distribution |
| MS497-M | Length 18 in | In distribution |
| VU421-M | Length 30 in | In distribution |
| VU422-SI | Length 27 in | In distribution |
| VU496-M | Length 18 in | In distribution |
| VU422-M | Length 30 in | In distribution |
| MS427-M | Length 30 in | In distribution |
| MS943-SI | Length 36 in | In distribution |
| V392-M | Length 18 in | In distribution |
| V466-SI | Length 27 in | In distribution |
| MS493-M | 5-0 | In distribution |
| MS923-MV | Length 36 in | In distribution |
| MS426-M | Length 30 in | In distribution |
| V463-SI | Length 18 in | In distribution |
| VU416-M | Length 30 in | In distribution |
| MS347-SI | Length 36 in | In distribution |
| V391-SI | Length 18 in | In distribution |
| V316-M | Length 30 in | In distribution |
| V339-M | Length 30 in | In distribution |
| MS315-M | Length 30 in | In distribution |
| V391-M | Length 18 in | In distribution |
| MS943-M | 2-0 | In distribution |
| MS464-P | Length 18 in | In distribution |
| VF497-M | Length 18 in | In distribution |
| MS316-M | Length 30 in | In distribution |
| VU495-SI | Length 27 in | In distribution |
| VU441-M | Length 30 in | In distribution |
| VU493-SI | Length 18 in | In distribution |
| VU492-SI | Length 18 in | In distribution |
| VU422-P | Length 27 in | In distribution |
| VU441-SI | Length 27 in | In distribution |
| V393-M | Length 18 in | In distribution |
| VF493-M | 5-0 | In distribution |
| V489-SI | Length 18 in | In distribution |
| VF496-M | Length 18 in | In distribution |
| MS464-M | Length 18 in | In distribution |
| MS495-M | Length 18 in | In distribution |
| V463-M | Length 18 in | In distribution |
| VU495-M | Length 18 in | In distribution |
| MS315-SI | Length 27 in | In distribution |
| VU497-P | Length 18 in | In distribution |
| MS987-SI | Length 36 in | In distribution |
| VU497-M | Length 18 in | In distribution |
| MS496-P | Length 18 in | In distribution |
| V452-M | Length 30 in | In distribution |
| MS922-MV | Length 36 in | In distribution |
| MS732-M | Length 36 in | In distribution |
| V333-M | Length 30 in | In distribution |
| V392-SI | Length 18 in | In distribution |
| VU497-SI | Length 18 in | In distribution |
| VU416-P | Length 27 in | In distribution |
| V317-M | Length 30 in | In distribution |
| VU494-M | Length 18 in | In distribution |
| VU443-M | Length 30 in | In distribution |
| MS922-SI | Length 36 in | In distribution |
| V442-SI | Height 18 in | In distribution |
| MS732-SI | Length 36 in | In distribution |
| VU489-M | Length 18 in | In distribution |
| VU493-M | Length 18 in | In distribution |
| MS426-P | Length 27 in | In distribution |
| MS496-M | Length 18 in | In distribution |
| MS942-SI | Length 36 in | In distribution |
| MS943-MV | Length 36 in | In distribution |
| VU494-P | Length 18 in | In distribution |
| V466-M | 2-0 | In distribution |
| MS463-M | Length 18 in | In distribution |
| VU496-P | Length 18 in | In distribution |
| MS936-M | Length 30 in | In distribution |
| V393-SI | Length 18 in | In distribution |
| V489-M | 6-0 | In distribution |
| VU421-SI | Length 27 in | In distribution |
| VU492-P | Length 18 in | In distribution |
| V442-M | 3-0 | In distribution |
| MS494-M | Length 18 in | In distribution |
| VU442-M | Length 30 in | In distribution |
| MS942-MV | Length 36 in | In distribution |
| VU494-SI | Length 18 in | In distribution |
| V310-M | Length 30 in | In distribution |
| MS942-M | 3-0 | In distribution |
| V332-M | Length 30 in | In distribution |
| V453-MV | Length 30 in | In distribution |
| MS347-M | Length 36 in | In distribution |
| VU423-SI | Length 27 in | In distribution |
| MS936-P | Length 27 in | In distribution |
| V546-MP | Length 18 in | In distribution |
| VU496-SI | Length 18 in | In distribution |
| V464-SI | Length 18 in | In distribution |
| V464-M | Length 18 in | In distribution |
| V452-MV | Length 30 in | In distribution |
| VF494-M | Length 18 in | In distribution |
| MS316-SI | Length 27 in | In distribution |
| VU423-M | Length 30 in | In distribution |
| VU507-M | Length 18 in | In distribution |
| MS494-P | Length 18 in | In distribution |
| V311-M | Length 30 in | In distribution |
| MS497-P | Length 18 in | In distribution |
| MS495-P | Length 18 in | In distribution |
| MS463-P | Length 18 in | In distribution |
| V397-M | Length 30 in | In distribution |
| VU492-M | Length 18 in | In distribution |
| VU493-P | Length 18 in | 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
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.