Sklar®
Safe Model Sterilization Container. Full Size with Silver Lid and Non-Perforated Bottom. Additional solid lid to protect filter lid.
5manufacturers in China registered for this device type
363catalogue numbers in this listing
1510(k) clearance
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 | Sklar Corporation, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K091720 |
| Record published | 2016-10-14 |
| Record revised | 2023-04-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-4324 | In distribution | ||
| 10-4404 | In distribution | ||
| 10-4242 | In distribution | ||
| 10-4346 | In distribution | ||
| 10-4502 | In distribution | ||
| 10-4418 | In distribution | ||
| 10-4078 | In distribution | ||
| 10-4210 | In distribution | ||
| 10-4504 | In distribution | ||
| 10-4580 | In distribution | ||
| 10-4688 | In distribution | ||
| 10-4344 | In distribution | ||
| 10-4540 | In distribution | ||
| 10-4086 | In distribution | ||
| 10-4206 | In distribution | ||
| 10-4742 | In distribution | ||
| 10-4686 | In distribution | ||
| 10-4166 | In distribution | ||
| 10-4140 | In distribution | ||
| 10-4676 | In distribution | ||
| 10-4716 | In distribution | ||
| 10-4620 | In distribution | ||
| 10-4650 | In distribution | ||
| 10-4910S | 20 | In distribution | |
| 10-4152 | In distribution | ||
| 10-4646 | In distribution | ||
| 10-4394 | In distribution | ||
| 10-4740 | In distribution | ||
| 10-4410 | In distribution | ||
| 10-4516 | In distribution | ||
| 10-4004 | In distribution | ||
| 10-4134 | In distribution | ||
| 10-4088 | In distribution | ||
| 10-4328 | In distribution | ||
| 10-4308 | In distribution | ||
| 10-4596 | In distribution | ||
| 10-4438 | In distribution | ||
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| 10-4542 | In distribution | ||
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| 99-4910 | 100 | In distribution | |
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Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Medline | Medline Industries, Inc. | 162 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091720 | 2010-04-09 |
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.