Symmetry Surgical®
Ultra® Container, Oval Filter, For Small & Endoscopic Containers, Single Use, (1000/bx)
5manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K092437 |
| Record published | 2016-05-27 |
| Record revised | 2025-10-29 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 6 to 12 in; width 2.5 in |
| Distribution end date | 2025-01-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51-0010B | Length 10 in | In distribution |
| FL-5 | In distribution | |
| 51-0012 | Width 2.5 in | In distribution |
| 51-0008 | Length 8 in | In distribution |
| FL-11 | In distribution | |
| 51-0008B | Length 8 in | In distribution |
| 51-0010 | Width 2.5 in | In distribution |
| 51-0006B | Length 6 in | In distribution |
| 51-0006 | Width 2.5 in | In distribution |
| 20-1020 | Withdrawn | |
| KB9 | Withdrawn | |
| SB10 | Withdrawn | |
| 50-9105 | Withdrawn | |
| KB4 | Withdrawn | |
| KB5 | Withdrawn | |
| 2001 | Withdrawn | |
| TAG-RECTANGLE | Withdrawn | |
| SB5 | Withdrawn | |
| KB7 | Withdrawn | |
| KB3 | Withdrawn | |
| KB2 | Withdrawn | |
| 22-0507-LD | Withdrawn | |
| KB10 | Withdrawn | |
| KB1 | Withdrawn | |
| 2000-300-015 | Withdrawn | |
| 2000-300-026 | Withdrawn | |
| 2000-300-018 | Withdrawn | |
| AS84 | Withdrawn | |
| SB7 | Withdrawn | |
| KB16 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Symmetry Medical/SSI | 510(k) number | 2013-12-05 | Class II | Process control | The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. | 2,991 units | 2015-04-13 |
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.