ALM SET
ALM SET Slim Line 20GX100MM
3manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | H.S. Hospital Service SPA |
|---|---|
| FDA product code | MIJ |
| Device type | Needle, Tumor Localization |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2023-04-19 |
| Record revised | 2023-09-18 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 10 |
| Sizes | Length 75 to 150 mm; needle gauge 20 to 21 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALM SET Z TYPE | Length 100 mm | In distribution |
| ALM SET V TYPE | Needle Gauge 20 G | In distribution |
| ALM SET V TYPE | Length 100 mm | In distribution |
| ALM SET V TYPE | Length 75 mm | In distribution |
| ALM SET S TYPE | Length 100 mm | In distribution |
| ALM SET V TYPE | Length 150 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kopans | Cook Incorporated | 27 |
| Medwire | Medax Srl Unipersonale | 22 |
| Sinurep | Medax Srl Unipersonale | 9 |
| 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 |
| Duo System Stereo | 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.