Device, Percutaneous, Biopsy
3 catalogue numbers from ERB7_ERB Biopsy Attachment, listed by GE Healthcare Japan Corporation, Japan, under Device, Percutaneous, Biopsy. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Tianjin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Tianjin Newtrans Technology Development | Tianjin | Tianjin | Exporter | 11 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | GE Healthcare Japan Corporation, Japan |
|---|---|
| FDA product code | MJG |
| Device type | Device, Percutaneous, Biopsy |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-15 |
| Record revised | 2026-01-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Storage environment temperature -40 to 60 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment humidity 30 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ERB7_ERB Biopsy Attachment | In distribution | |
| E8C Reusable Guide Attachment | In distribution | |
| MTZ Biopsy Guide Attachment | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 392 |
| Cook | Cook Incorporated | 77 |
| Intro | M.D.L. S.R.L. | 34 |
| Franseen | Cook Incorporated | 32 |
| HandCut | M.D.L. S.R.L. | 22 |
| Turner | Cook Incorporated | 15 |
| Palium Needle | M.D.L. S.R.L. | 14 |
| Primocut | Pajunk Gmbh Medizintechnologie | 13 |
| FastCutP | M.D.L. S.R.L. | 10 |
| Co-Axial Cannula Bundle | Argon Medical Devices, Inc. | 10 |
| Medline Industries, Inc. | Medline Industries, Inc. | 10 |
| Greene | Cook Incorporated | 10 |
Showing 12 of 44. All products under Device, Percutaneous, Biopsy
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.