Optime®
295 catalogue numbers from 18I40V, listed by Peters Surgical, France, under Suture, Absorbable, Synthetic, Polyglycolic Acid. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
295catalogue numbers in this listing
3510(k) clearances naming this product 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 | 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) | K062366 |
| Record published | 2020-01-09 |
| Record revised | 2023-07-12 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 36, pack of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18I40V | In distribution | |
| 18B15E | In distribution | |
| 18S40U | In distribution | |
| 18I40P | In distribution | |
| 18S35AE | In distribution | |
| 18S30B | In distribution | |
| 18I10J | In distribution | |
| 18S35C | In distribution | |
| 18I15L | In distribution | |
| 18B20B | In distribution | |
| 18N15P | In distribution | |
| 18I10F | In distribution | |
| 18S20AP | In distribution | |
| 18S20AB | In distribution | |
| 18S35T | In distribution | |
| 18S35AG | In distribution | |
| 18S10E | In distribution | |
| 18G35AF | In distribution | |
| 18S50H | In distribution | |
| 18S35AV | In distribution | |
| 18G50B | In distribution | |
| 18S40AT | In distribution | |
| 18G30W | In distribution | |
| 18N20R | In distribution | |
| 18I20P | In distribution | |
| 18B35C | In distribution | |
| 18S35M | In distribution | |
| 18N30E | In distribution | |
| 18B35E | In distribution | |
| 18S30K | In distribution | |
| 18BI35E | In distribution | |
| 18R40B | In distribution | |
| 18N15F | In distribution | |
| 18S15N | In distribution | |
| 18S40T | In distribution | |
| 18S50AF | In distribution | |
| 18B20E | In distribution | |
| 18S40AA | In distribution | |
| 18I35N | In distribution | |
| 18S30AC | In distribution | |
| 18B40B | In distribution | |
| 18I35K | In distribution | |
| 18S30W | In distribution | |
| 18S30WA | In distribution | |
| 18B40F | In distribution | |
| 18I20M | In distribution | |
| 18S20C | In distribution | |
| 18B50D | In distribution | |
| 18S20F | In distribution | |
| 18RI40A | In distribution | |
| 18B20A | In distribution | |
| 18I30AM | In distribution | |
| 18I35T | In distribution | |
| 18B15D | In distribution | |
| 18I30P | In distribution | |
| 18S30U | In distribution | |
| 18S30Z | In distribution | |
| 18S20W | In distribution | |
| 18N10C | In distribution | |
| 18S10Q | In distribution | |
| 18R15B | In distribution | |
| 18S40S | In distribution | |
| 18S20V | In distribution | |
| 18S20J | In distribution | |
| 18I15J | In distribution | |
| 18N20F | In distribution | |
| 18G35B | In distribution | |
| 18S35AW | In distribution | |
| 18I35AB | In distribution | |
| 18S40G | In distribution | |
| 18S20K | In distribution | |
| 18B40D | In distribution | |
| 18S30AW | In distribution | |
| 18S20U | In distribution | |
| 18G50A | In distribution | |
| 18S30AL | In distribution | |
| 18I30J | In distribution | |
| 18I30L | In distribution | |
| 18I07D | In distribution | |
| 18S40H | In distribution | |
| 18S10J | In distribution | |
| 18S50C | In distribution | |
| 18S20L | In distribution | |
| 18S30E | In distribution | |
| 18S10C | In distribution | |
| 18S10S | In distribution | |
| 18I07J | In distribution | |
| 18S15P | In distribution | |
| 18N30A | In distribution | |
| 18B20D | In distribution | |
| 18G40L | In distribution | |
| 18S50Y | In distribution | |
| 18S15D | In distribution | |
| 18S30R | In distribution | |
| 18B50A | In distribution | |
| 18S40AD | In distribution | |
| 18G30H | In distribution | |
| 18S30P | In distribution | |
| 18S15F | In distribution | |
| 18S35P | In distribution | |
| 18S40R | In distribution | |
| 18I15S | In distribution | |
| 18RI20A | In distribution | |
| 18S30D | In distribution | |
| 18S10A | In distribution | |
| 18S15K | In distribution | |
| 18I07G | In distribution | |
| 18S30AQ | In distribution | |
| 18S07A | In distribution | |
| 18G50T | In distribution | |
| 18S20G | In distribution | |
| 18I20F | In distribution | |
| 18I40N | In distribution | |
| 18I10G | In distribution | |
| 18S07H | In distribution | |
| 18BI30E | In distribution | |
| 18S10N | In distribution | |
| 18S15B | In distribution | |
| 18S15E | In distribution | |
| 18S30S | In distribution | |
| 18N15B | In distribution | |
| 18R50A | In distribution | |
| 18N30B | In distribution | |
| 18I20N | In distribution | |
| 18S20AS | In distribution | |
| 18B15A | In distribution | |
| 18S30A | In distribution | |
| 18I35L | In distribution | |
| 18S15G | In distribution | |
| 18N30F | In distribution | |
| 18B15C | In distribution | |
| 18B40C | In distribution | |
| 18S40M | In distribution | |
| 18B30A | In distribution | |
| 18S40BC | In distribution | |
| 18B30E | In distribution | |
| 18G40F | In distribution | |
| 18B50C | In distribution | |
| 18RI30A | In distribution | |
| 18N15E | In distribution | |
| 18S20B | In distribution | |
| 18I40K | In distribution | |
| 18S50E | In distribution | |
| 18BI10E | In distribution | |
| 18RI35A | In distribution | |
| 18S15R | In distribution | |
| 18S40W | In distribution | |
| 18I10E | In distribution | |
| 18S15Q | In distribution | |
| 18R10B | In distribution | |
| 18S35R | In distribution | |
| 18S35AX | In distribution | |
| 18R30B | In distribution | |
| 18I30K | In distribution | |
| 18S20R | In distribution | |
| 18G50M | In distribution | |
| 18B20C | In distribution | |
| 18S10K | In distribution | |
| 18S50J | In distribution | |
| 18S30L | In distribution | |
| 18S50P | In distribution | |
| 18S35D | In distribution | |
| 18R20A | In distribution | |
| 18B10D | In distribution | |
| 18S30M | In distribution | |
| 18B30F | In distribution | |
| 18S20N | In distribution | |
| 18S20Z | In distribution | |
| 18S35H | In distribution | |
| 18BI15E | In distribution | |
| 18R30A | In distribution | |
| 18S30AY | In distribution | |
| 18N20E | In distribution | |
| 18S20AC | In distribution | |
| 18N20B | In distribution | |
| 18S50G | In distribution | |
| 18S20Q | In distribution | |
| 18S35F | In distribution | |
| 18S35E | In distribution | |
| 18B20F | In distribution | |
| 18I20AA | In distribution | |
| 18I30E | In distribution | |
| 18S50AE | In distribution | |
| 18S40X | In distribution | |
| 18S30F | In distribution | |
| 18S30J | In distribution | |
| 18I20L | In distribution | |
| 18I30B | In distribution | |
| 18I15H | In distribution | |
| 18S30AE | In distribution | |
| 18S20AR | In distribution | |
| 18BI20E | In distribution | |
| 18I20K | In distribution | |
| 18S15A | In distribution | |
| 18S35L | In distribution | |
| 18S30N | In distribution | |
| 18S30AH | In distribution | |
| 18S30AV | In distribution | |
| 18G40AD | In distribution | |
| 18I20U | In distribution | |
| 18S30AD | In distribution | |
| 18B30D | In distribution | |
| 18S20A | In distribution | |
| 18S20E | In distribution | |
| 18S30AK | In distribution | |
| 18G40D | In distribution | |
| 18S40BB | In distribution | |
| 18S20H | In distribution | |
| 18S20AA | In distribution | |
| 18S20AM | In distribution | |
| 18S20M | In distribution | |
| 18R35B | In distribution | |
| 18I30S | In distribution | |
| 18S40P | In distribution | |
| 18I20J | In distribution | |
| 18B40E | In distribution | |
| 18I10H | In distribution | |
| 18B10E | In distribution | |
| 18S35N | In distribution | |
| 18S30G | In distribution | |
| 18S40AF | In distribution | |
| 18I50G | In distribution | |
| 18S50L | In distribution | |
| 18R35A | In distribution | |
| 18N15C | In distribution | |
| 18S35K | In distribution | |
| 18S30C | In distribution | |
| 18S40K | In distribution | |
| 18I20E | In distribution | |
| 18I50N | In distribution | |
| 18G40Z | In distribution | |
| 18S35A | In distribution | |
| 18S35J | In distribution | |
| 18B15F | In distribution | |
| 18R15A | In distribution | |
| 18B30C | In distribution | |
| 18S15C | In distribution | |
| 18S40AC | In distribution | |
| 18S40D | In distribution | |
| 18BI40E | In distribution | |
| 18I35AD | In distribution | |
| 18B35B | In distribution | |
| 18B35A | In distribution | |
| 18B30B | In distribution | |
| 18B40A | In distribution | |
| 18S10B | In distribution | |
| 18B50B | In distribution | |
| 18S10T | In distribution | |
| 18S40AB | In distribution | |
| 18S35AH | In distribution |
Showing 250 of 295 catalogue numbers.
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.