IMS
Universal Keyhole Bracket, 10 position, 2 tier, 5/3mm vertical slots, silicone height 38.1mm(1.5"), OL 191.77mm(7 1/2")
5manufacturers in China registered for this device type
37catalogue 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 | Avalign Technologies, 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 | Specification developer, Manufacturer |
| Record published | 2017-05-22 |
| Record revised | 2023-07-06 (version 7) |
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 |
| Sizes | Height 4 in; width 20 in; length 9 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95-2000100012 | In distribution | |
| 95-2000100001 | In distribution | |
| 95-2000162033 | In distribution | |
| 95-2000162012 | In distribution | |
| 95-2000162011 | In distribution | |
| 95-2000100027 | In distribution | |
| 95-2000162010 | In distribution | |
| 95-2000100023 | In distribution | |
| 95-2000100019 | In distribution | |
| 95-2000162050 | In distribution | |
| 95-2000162056 | In distribution | |
| 95-2000100022 | In distribution | |
| 95-2000100020 | In distribution | |
| 95-2000100034 | In distribution | |
| 95-2000100009 | In distribution | |
| 95-2000100007 | In distribution | |
| 95-2000162004 | In distribution | |
| 95-2000100035 | In distribution | |
| 95-2000162046 | In distribution | |
| 95-2000162049 | In distribution | |
| 95-2000162020 | In distribution | |
| 95-2000100022 | In distribution | |
| 95-2000300018 | In distribution | |
| 95-2000162008 | In distribution | |
| 95-2000162014 | In distribution | |
| 95-2000100027 | In distribution | |
| 95-2000100086 | In distribution | |
| 95-2000162031 | In distribution | |
| 95-2000100008 | In distribution | |
| 95-2000162063 | In distribution | |
| 95-2000100005 | In distribution | |
| 95-2000162054 | In distribution | |
| 95-2000162048 | In distribution | |
| 95-2000162055 | In distribution | |
| 95-2000100002 | In distribution | |
| 95-2000162021 | In distribution | |
| 95-2000100005 | Height 4 in | In distribution |
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 |
|---|---|
| K193066 | 2020-08-06 |
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.