Custom Healthcare Systems, Inc.
11 catalogue numbers from KM-19370, listed by Manus Medical, LLC, United States, under Needle, Biopsy, Cardiovascular. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Wenzhou Aochang Misawa Medical Tech. Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Manus Medical, LLC, United States |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-03 |
| Record revised | 2023-06-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, na of 20, n/a of 20, na of 10, pack of 5, pack of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KM-19370 | In distribution | |
| YMNPT-100A | In distribution | |
| KM-19382 | In distribution | |
| KM-19370-1 | In distribution | |
| 3404253NBN | In distribution | |
| YMNPT-PARK22 | In distribution | |
| 1116803015 | In distribution | |
| VBS-19108 | In distribution | |
| BMTX-1009D | In distribution | |
| BMTX-1047 | In distribution | |
| 10-2178 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M-Biopsy Needle For Reusable Biopsy Instruments | Mermaid Medical A/S | 55 |
| Biocore II MG | Histo S.A. | 33 |
| Biocore II TC | Histo S.A. | 26 |
| UltraCore™ Biopsy Needle | Argon Medical Devices, Inc. | 18 |
| Illy | M.D.L. S.R.L. | 16 |
| Biocore II BR | Histo S.A. | 15 |
| PenBone | M.D.L. S.R.L. | 14 |
| Biocore II | Histo S.A. | 14 |
| PickUp | M.D.L. S.R.L. | 12 |
| PressTo | M.D.L. S.R.L. | 10 |
| OsteoJ | M.D.L. S.R.L. | 10 |
| Mamawire Plus | Histo S.A. | 6 |
Showing 12 of 28. All products under Needle, Biopsy, Cardiovascular
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.