Busse Hospital Disposables
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle
2manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Robert Busse & Co., Inc., United States |
|---|---|
| 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 | 2020-12-14 |
| Record revised | 2024-10-15 (version 3) |
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 |
| Packaging | Pack of 10 |
| Distribution end date | 2024-10-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8673R7 | In distribution | |
| 2177 | In distribution | |
| 2143 | In distribution | |
| 977 | In distribution | |
| 1298 | Withdrawn |
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 |
| Medichoice | Owens & Minor Distribution, Inc. | 1 |
| CleanFreak® | Diversatek Healthcare Inc | 1 |
| Halyard | Avid Medical, Inc. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Busse Hospital Disposables | UDI-DI | 2022-02-22 | Class II | Other | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test method | 285 units | 2024-04-17 |
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.