AngioSystems Tray
126 catalogue numbers from 5120, listed by Angiosystems, Inc., United States, under Tray, Surgical. 36 manufacturers in China are registered for this product code.
36manufacturers in China registered for this device type
126catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangdong Huilin Packaging Technology Group Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 36. All 36 manufacturers in China registered for Tray, Surgical
Record
| Listed by | Angiosystems, Inc., United States |
|---|---|
| FDA product code | LRP |
| Device type | Tray, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K905462 |
| Record published | 2018-09-03 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 10, pack of 30, pack of 5, pack of 6, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5120 | In distribution | |
| 7026 | In distribution | |
| 5021-1 | In distribution | |
| 5621-8 | In distribution | |
| KM5052 | In distribution | |
| 5602-8 | In distribution | |
| 1002-2 | In distribution | |
| 5681 | In distribution | |
| KM5042 | In distribution | |
| KM5063 | In distribution | |
| KM5069 | In distribution | |
| 5713 | In distribution | |
| 5621 | In distribution | |
| 5845 | In distribution | |
| 5800 | In distribution | |
| 5744 | In distribution | |
| KM5067 | In distribution | |
| 43545-3 | In distribution | |
| 5811 | In distribution | |
| 5048-7 | In distribution | |
| 5805 | In distribution | |
| KM5068 | In distribution | |
| 5531 | In distribution | |
| 7021 | In distribution | |
| 5680-30 | In distribution | |
| 5750 | In distribution | |
| KM5023 | In distribution | |
| KM5064 | In distribution | |
| 5456 | In distribution | |
| KM5044 | In distribution | |
| 5559 | In distribution | |
| KM5056 | In distribution | |
| 5690 | In distribution | |
| KM5032-5 | In distribution | |
| 5700 | In distribution | |
| KM5076 | In distribution | |
| KM5035 | In distribution | |
| 7025-1 | In distribution | |
| KM5057 | In distribution | |
| 5220 | In distribution | |
| 5807 | In distribution | |
| KM5050-5 | In distribution | |
| KM5058 | In distribution | |
| 7027 | In distribution | |
| KM5074 | In distribution | |
| KM5021 | In distribution | |
| KM5065 | In distribution | |
| 5049 | In distribution | |
| KM5045 | In distribution | |
| KM5077 | In distribution | |
| 5742 | In distribution | |
| 5670 | In distribution | |
| 5634 | In distribution | |
| 7020-2 | In distribution | |
| KM5055 | In distribution | |
| KM5029 | In distribution | |
| 5694 | In distribution | |
| 5680-4 | In distribution | |
| 7020-3 | In distribution | |
| 5550 | In distribution | |
| 5842 | In distribution | |
| KM5073 | In distribution | |
| KM5050 | In distribution | |
| KM5009 | In distribution | |
| KM5071 | In distribution | |
| KM5024-8 | In distribution | |
| 5680-7 | In distribution | |
| 5745 | In distribution | |
| 1056 | In distribution | |
| KM5075 | In distribution | |
| KM5061 | In distribution | |
| 5602-12 | In distribution | |
| KM5030 | In distribution | |
| 5743 | In distribution | |
| KM5059 | In distribution | |
| 5572 | In distribution | |
| KM5031 | In distribution | |
| 5686-11 | In distribution | |
| KM5072 | In distribution | |
| KM5025 | In distribution | |
| KM5022 | In distribution | |
| 5680-11 | In distribution | |
| 7015 | In distribution | |
| KM5024 | In distribution | |
| 5663 | In distribution | |
| 7010 | In distribution | |
| 5744-5 | In distribution | |
| 5671 | In distribution | |
| 5680-7 | In distribution | |
| 5808 | In distribution | |
| 5050 | In distribution | |
| KM5034 | In distribution | |
| 1000 | In distribution | |
| 5732 | In distribution | |
| 1015 | In distribution | |
| 5734 | In distribution | |
| 5556 | In distribution | |
| KM5032 | In distribution | |
| 5840 | In distribution | |
| 1036 | In distribution | |
| 5841 | In distribution | |
| 5734-1 | In distribution | |
| 5703 | In distribution | |
| 5125 | In distribution | |
| KM5078 | In distribution | |
| KM5020 | In distribution | |
| 5743-5 | In distribution | |
| 1056-1 | In distribution | |
| 5021-2 | In distribution | |
| KM5070 | In distribution | |
| KM5017 | In distribution | |
| 5612 | In distribution | |
| 5715 | In distribution | |
| 5702 | In distribution | |
| KM5066 | In distribution | |
| KM5043 | In distribution | |
| KM5054 | In distribution | |
| 7020-1 | In distribution | |
| 3404599-1(3) | In distribution | |
| KM5028 | In distribution | |
| KM5014 | In distribution | |
| KM5061-1 | In distribution | |
| 5680-20 | In distribution | |
| 1055 | In distribution | |
| KM5062 | In distribution | |
| 7020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 12,037 |
| Centurion | Centurion Medical Products Corporation | 2,023 |
| Medline | Medline Industries, Inc. | 773 |
| PST Trays | Ambler Surgical, LLC | 128 |
| Tray, Surgical | Wright Medical Technology, Inc. | 123 |
| Medin Corporation | Ambler Surgical, LLC | 96 |
| Aligned Medical Solutions | Aligned Medical Solutions | 92 |
| Stradis | Stradis Healthcare | 91 |
| Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. | 90 |
| SteriBest | Surgical Products Corp. | 84 |
| Elmed | Elmed, Inc. | 79 |
| SteriBest | Mastel Surgical Inc. | 76 |
Showing 12 of 808. All products under Tray, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K905462 | 1991-02-06 |
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.