Integra® Miltex®
Integra® Miltex® Miltex® Cassette, Statim 8 7-3/32" x 8-1/32" x 1-5/32" (18cm x 20.4cm x 2.9cm)
5manufacturers in China registered for this device type
71catalogue 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 | Integra LifeSciences Production 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 | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K012105 |
| Record published | 2016-08-26 |
| Record revised | 2024-03-06 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3-085009 | In distribution | |
| 4-085000 | In distribution | |
| STDSTAT814 | In distribution | |
| STDWVOS | In distribution | |
| 3-084107 | In distribution | |
| 3-072014 | In distribution | |
| STDBOL | In distribution | |
| 3-118122 | In distribution | |
| 4-6835 | In distribution | |
| STDSL27 | In distribution | |
| STDORTHO | In distribution | |
| STD209 | In distribution | |
| 3-139000UOK | In distribution | |
| STDPB | In distribution | |
| 3-085218 | In distribution | |
| 4-008122 | In distribution | |
| 3200100A | In distribution | |
| 3-083105 | In distribution | |
| 3-082008 | In distribution | |
| 3-200100 | In distribution | |
| 3-084214 | In distribution | |
| STDBOS | In distribution | |
| 3-139126 | In distribution | |
| STDORTHOS | In distribution | |
| 3-200300 | In distribution | |
| 3-080205 | In distribution | |
| 3-089110 | In distribution | |
| 46815 | In distribution | |
| 4-009126 | In distribution | |
| 3-084007 | In distribution | |
| STD222 | In distribution | |
| 3-085109 | In distribution | |
| 3-200200 | In distribution | |
| STDSTAT8 | In distribution | |
| STDBOM | In distribution | |
| 3-083210 | In distribution | |
| 3-072007 | In distribution | |
| 4-008115 | In distribution | |
| 3-087000UKRD | In distribution | |
| 3-118114 | In distribution | |
| 3-083005 | In distribution | |
| 3-118116 | In distribution | |
| 3-139126UKPEDO | Withdrawn | |
| 4-089100 | Withdrawn | |
| 4-084000 | Withdrawn | |
| STDES72 | Withdrawn | |
| 3-118114UKC | Withdrawn | |
| 3-118114UKENDO | Withdrawn | |
| 3-089110L | Withdrawn | |
| STDSTAT | Withdrawn | |
| 3118122UTX | Withdrawn | |
| 3-089110A | Withdrawn | |
| 3-200100ZIM | Withdrawn | |
| 3-118114L | Withdrawn | |
| 3-118116S | Withdrawn | |
| STDES48 | Withdrawn | |
| 3-118116A | Withdrawn | |
| 3-118114S | Withdrawn | |
| STDES60 | Withdrawn | |
| STDBP | Withdrawn | |
| 4-083000 | Withdrawn | |
| 3-118122UK1 | Withdrawn | |
| 3200300A | Withdrawn | |
| 3-118116L | Withdrawn | |
| 3-200300ZIM | Withdrawn | |
| 3-200200ZIM | Withdrawn | |
| 3-118122UKOP | Withdrawn | |
| 3-118114UKORTHO | Withdrawn | |
| 3-084107UKBD | Withdrawn | |
| 3-084207 | Withdrawn | |
| 3-118114UBC | 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
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.