Optime R
Optime R is a sterile absorbable multifilament suture for general soft tissue approximation when short-term wound support and rapid strength loss are needed. Uses include ophthalmic…
Optime R is a sterile absorbable multifilament suture for general soft tissue approximation when short-term wound support and rapid strength loss are needed. Uses include ophthalmic procedures, with cardiovascular and neurological procedures excluded.
The undyed braided thread is made from polyglycolic acid and may be supplied with an attached disposable needle. A coating combines polycaprolactone and calcium stearate.
Surgical Use and Supply
The suture is intended for open or laparoscopic suturing. The needle passes the thread through tissue and knots secure approximation. Each device is single use and sterilized by gamma irradiation.
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 | Peters Surgical, France |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K233265 |
| Record published | 2025-01-09 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12S40P | In distribution | |
| 12S20T | In distribution | |
| 12S30C | In distribution | |
| 12S30B | In distribution | |
| 12S20Q | In distribution | |
| 12S30A | In distribution | |
| 12S10F | In distribution | |
| 12S20L | In distribution | |
| 12S15F | In distribution | |
| 12N15G | In distribution | |
| 12S40A | In distribution | |
| 12S15B | In distribution | |
| 12S30G | In distribution | |
| 12N20G | In distribution | |
| 12S10H | In distribution | |
| 12D10A | In distribution | |
| 12S35B | In distribution | |
| 12S40F | In distribution | |
| 12S30F | In distribution | |
| 12S10B | In distribution | |
| 12S10D | In distribution | |
| 12S35A | In distribution | |
| 12S30V | In distribution | |
| 12S35D | In distribution | |
| 12S30AL | In distribution | |
| 12S40C | In distribution | |
| 12S40H | In distribution | |
| 12S20E | In distribution | |
| 12S15U | In distribution | |
| 12S07C | In distribution | |
| 12S07A | In distribution | |
| 12S35C | In distribution | |
| 12S15V | In distribution | |
| 12S15C | In distribution | |
| 12S20V | In distribution | |
| 12S10G | In distribution | |
| 12S30E | In distribution | |
| 12S20G | In distribution | |
| 12S15A | In distribution | |
| 12S35G | In distribution | |
| 12S20S | In distribution | |
| 12S20A | In distribution | |
| 12S40D | In distribution | |
| 12S20C | In distribution | |
| 12S30J | In distribution | |
| 12S20F | In distribution | |
| 12S20D | In distribution | |
| 12S20K | In distribution | |
| 12S40B | In distribution | |
| 12S15D | In distribution | |
| 12S15R | In distribution | |
| 12S35E | In distribution | |
| 12S30N | In distribution | |
| 12S30D | In distribution | |
| 12S30U | In distribution | |
| 12S35F | In distribution | |
| 12S15T | In distribution | |
| 12S15H | In distribution | |
| 12S35H | In distribution | |
| 12S15E | In distribution | |
| 12S40N | In distribution | |
| 12S15G | In distribution | |
| 12S10C | In distribution | |
| 12S20B | In distribution | |
| 12S20U | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233265 | 2024-10-11 |
| K232372 | 2024-07-12 |
| K062366 | 2006-10-02 |
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.