Sterimed
3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clear (TC3B) Non-Sterile
7manufacturers in China registered for this device type
114catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Sterimed, Inc., United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K853044 |
| Record published | 2017-01-24 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 8, inner pack/box of 25, case of 4, case of 100, inner pack/box of 5, inner pack/box of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A0890 | In distribution | |
| 4425 | In distribution | |
| 0184B | In distribution | |
| PC0596 | In distribution | |
| A0307 | In distribution | |
| 0785B | In distribution | |
| MB0062 | In distribution | |
| 0120 | In distribution | |
| 4440TB | In distribution | |
| ZB0096 | In distribution | |
| VC0796C | In distribution | |
| PC0524 | In distribution | |
| 2012T | In distribution | |
| 2840 | In distribution | |
| ZG1001 | In distribution | |
| BC0507 | In distribution | |
| RC0596 | In distribution | |
| 0284-2 | In distribution | |
| 4120S | In distribution | |
| MR0120 | In distribution | |
| 0587W-1 | In distribution | |
| 0130B | In distribution | |
| 0986B | In distribution | |
| 4480B | In distribution | |
| VC1018B | In distribution | |
| 0888NT | In distribution | |
| MB0096 | In distribution | |
| VC0980P | In distribution | |
| 4456S | In distribution | |
| 0136 | In distribution | |
| 0886 | In distribution | |
| 0120X | In distribution | |
| 0586S | In distribution | |
| AR1096-2 | In distribution | |
| 4440B | In distribution | |
| A0712 | In distribution | |
| VC0796 | In distribution | |
| 0586L | In distribution | |
| 3520SB | In distribution | |
| PC0596B | In distribution | |
| 4425B | In distribution | |
| 0484B | In distribution | |
| A1918 | In distribution | |
| 0514 | In distribution | |
| PC0512 | In distribution | |
| 0484-18B | In distribution | |
| ZG1007 | In distribution | |
| TR0105B | In distribution | |
| MG0056 | In distribution | |
| ZB1005 | In distribution | |
| 0888 | In distribution | |
| 0130 | In distribution | |
| 4454 | In distribution | |
| 0136B | In distribution | |
| 2023 | In distribution | |
| WG0105 | In distribution | |
| 4065MI | In distribution | |
| 4065 | In distribution | |
| 0585 | In distribution | |
| 0284 | In distribution | |
| 0888M | In distribution | |
| 0586 | In distribution | |
| 4480W | In distribution | |
| 0384 | In distribution | |
| WR0150 | In distribution | |
| PB1003 | In distribution | |
| VC0996PF | In distribution | |
| 0484-18 | In distribution | |
| 0585B | In distribution | |
| ZG0082 | In distribution | |
| 4065X | In distribution | |
| 0986 | In distribution | |
| WR0120 | In distribution | |
| A4702 | In distribution | |
| 0587W | In distribution | |
| 0184 | In distribution | |
| 4440 | In distribution | |
| 4480SB | In distribution | |
| A0192 | In distribution | |
| 0141B | In distribution | |
| VC0796P | In distribution | |
| 5380W | In distribution | |
| 0914 | In distribution | |
| 0785 | In distribution | |
| 4480S | In distribution | |
| VC0996 | In distribution | |
| 2015B | In distribution | |
| RC0996 | In distribution | |
| ZO1000T | In distribution | |
| PC0796 | In distribution | |
| TC3B | In distribution | |
| 0587WB | In distribution | |
| MR0150 | In distribution | |
| BD92126 | In distribution | |
| ZG1006 | In distribution | |
| PC0548 | In distribution | |
| VC0596 | In distribution | |
| 4454X | In distribution | |
| VC0596P | In distribution | |
| RC0796 | In distribution | |
| 0586L-R | In distribution | |
| 0586B | In distribution | |
| 3692 | In distribution | |
| 4440T | In distribution | |
| 0886B | In distribution | |
| 0786 | In distribution | |
| 0141 | In distribution | |
| VC0796CS | In distribution | |
| WR1010 | In distribution | |
| MG0105 | In distribution | |
| PC0548CS | In distribution | |
| 0484 | In distribution | |
| 0120XB | In distribution | |
| MR0082 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
| Leica FL800 ULT | Leica Microsystems (Schweiz) AG | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K853044 | 1985-11-01 |
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.