CleanFreak®
Endoscope Transport Pad
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 | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FCH |
| Device type | Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2019-10-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1201-90 | 25 | 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 |
| Medichoice | Owens & Minor Distribution, 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.