Medichoice
X Rx Tray Biopsy Soft-Tissue Basic Single-Patient Use Latex-Free Sterile MediChoice
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Owens & Minor Distribution, Inc. |
|---|---|
| FDA product code | FCH |
| Device type | Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Premarket notification | Exempt |
| Record published | 2016-08-29 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid freezing and excessive heat; Handling environment temperature 68 to 77 °F |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STB651 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACS | American Contract Systems, Inc. | 86 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 65 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| Therapak | Therapak, LLC | 12 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 5 |
| CleanFreak® | Diversatek Healthcare Inc | 1 |
| Halyard | Avid Medical, Inc. | 1 |
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.