DKBL-21-7.0-A
Catalogue number G03507, listed by IZI Medical Products LLC, United States, under Needle, Tumor Localization. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | IZI Medical Products LLC, United States |
|---|---|
| FDA product code | MIJ |
| Device type | Needle, Tumor Localization |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G03507 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kopans | Cook Incorporated | 27 |
| Medwire | Medax Srl Unipersonale | 22 |
| Sinurep | Medax Srl Unipersonale | 9 |
| ALM SET | H.S. Hospital Service SPA | 6 |
| Cook | Cook Incorporated | 5 |
| Tuflex | Somatex Medical Technologies GmbH | 4 |
| Breast Needle Locator | Remington Medical, Inc. | 4 |
| Q-Wire System | Somatex Medical Technologies GmbH | 3 |
| Tuloc Premium | Somatex Medical Technologies GmbH | 3 |
| Tuloc | Somatex Medical Technologies GmbH | 3 |
| Tuflex Premium | Somatex Medical Technologies GmbH | 3 |
| MRI Tuloc | Somatex Medical Technologies GmbH | 2 |
Showing 12 of 37. All products under Needle, Tumor Localization
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.