Aesculap
Bottom, without base perforation, Standard 3/4, aluminium, silver, outer length: 470 mm, outer width: 274 mm, outer heigth: 187 mm,inner length: 421 mm, inner width: 258 mm, inner heigth:…
Bottom, without base perforation, Standard 3/4, aluminium, silver, outer length: 470 mm, outer width: 274 mm, outer heigth: 187 mm,inner length: 421 mm, inner width: 258 mm, inner heigth: 160 mm
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 | Aesculap AG, Germany |
|---|---|
| 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, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2023-04-04 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry place; Special storage condition: Avoid extreme temperature; Special storage condition: Store in a cool place |
| Distribution end date | 2026-07-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| JN444 | In distribution | ||
| JK089 | 10 | In distribution | |
| JS389 | In distribution | ||
| JP003 | In distribution | ||
| JP011 | In distribution | ||
| JS444 | In distribution | ||
| JM021 | In distribution | ||
| JP021 | In distribution | ||
| US992 | 1,000 | In distribution | |
| JS342 | In distribution | ||
| MD344 | 1,000 | In distribution | |
| JN744 | In distribution | ||
| US751 | 1,000 | In distribution | |
| JP050 | In distribution | ||
| JS740 | In distribution | ||
| JS789 | In distribution | ||
| JP007 | In distribution | ||
| US998 | 1,000 | In distribution | |
| JK490 | In distribution | ||
| JS441 | In distribution | ||
| JK090 | 10 | In distribution | |
| JS742 | In distribution | ||
| US905 | 1,000 | In distribution | |
| JS440 | In distribution | ||
| JN442 | In distribution | ||
| JP012 | In distribution | ||
| JK744 | In distribution | ||
| US994 | 1,000 | In distribution | |
| JS442 | In distribution | ||
| JS340 | In distribution | ||
| JM441 | In distribution | ||
| JS341 | In distribution | ||
| JM440 | In distribution | ||
| JS741 | In distribution | ||
| JS489 | In distribution | ||
| US999 | 1,000 | In distribution | |
| JM742 | Withdrawn | ||
| JP001 | Withdrawn | ||
| JM389 | Withdrawn | ||
| JP027 | Withdrawn | ||
| JP014 | Withdrawn | ||
| MA985 | Withdrawn | ||
| MD559 | Withdrawn | ||
| JP005 | Withdrawn | ||
| JP025 | Withdrawn | ||
| MD574 | Withdrawn | ||
| MA982 | Withdrawn | ||
| JM442 | Withdrawn | ||
| MD678 | Withdrawn | ||
| US020 | 4 | Withdrawn | |
| MD573 | Withdrawn | ||
| JP022 | Withdrawn | ||
| MA984 | Withdrawn | ||
| US021 | 4 | Withdrawn | |
| JP015 | Withdrawn | ||
| MA986 | Withdrawn | ||
| JM444 | Withdrawn | ||
| JP017 | Withdrawn | ||
| JP023 | Withdrawn | ||
| MD560 | Withdrawn | ||
| MA987 | Withdrawn | ||
| JP004 | Withdrawn | ||
| JP002 | Withdrawn | ||
| JP024 | Withdrawn | ||
| JP013 | Withdrawn | ||
| JM341 | Withdrawn | ||
| JM740 | Withdrawn | ||
| MD572 | Withdrawn | ||
| JM741 | Withdrawn | ||
| MD571 | Withdrawn | ||
| MD676 | Withdrawn | ||
| MD575 | Withdrawn | ||
| JP026 | Withdrawn | ||
| JP016 | Withdrawn | ||
| MD677 | Withdrawn | ||
| MD558 | Withdrawn | ||
| JP006 | Withdrawn | ||
| MD576 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242762 | 2025-05-13 |
| K214041 | 2022-12-30 |
| K192056 | 2020-03-27 |
| K193582 | 2020-03-17 |
| K182414 | 2019-07-05 |
| K182032 | 2018-12-21 |
| K172850 | 2017-11-17 |
| K162815 | 2017-07-13 |
| K151242 | 2015-10-09 |
| K143729 | 2015-08-18 |
| K142970 | 2015-07-08 |
| K112671 | 2012-05-04 |
| K073168 | 2008-04-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-09-08 | Class II | No Marketing Application | The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall. | 292 units | 2019-04-04 |
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.