Primocut
PrimoCut 18G (1,2) x 150mm sterile
5manufacturers in China registered for this device type
13catalogue numbers in this listing
1510(k) clearance
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 | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| FDA product code | MJG |
| Device type | Device, Percutaneous, Biopsy |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K080674 |
| Record published | 2021-07-12 |
| Record revised | 2025-12-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity 10 to 65 % RH |
| Packaging | Pack of 10 |
| Sizes | Length 280 mm; needle gauge 18 G |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 415S120200 | In distribution | ||
| 415S120280 | Length 280.0 mm | In distribution | |
| 415S120150 | In distribution | ||
| 415S120100 | In distribution | ||
| 415S120100 | 10 | Withdrawn | |
| 415S120150 | 10 | Withdrawn | |
| 415S120100 | 10 | Withdrawn | |
| 415S120200 | 10 | Withdrawn | |
| 415S120100 | 10 | Withdrawn | |
| 415S120150 | 10 | Withdrawn | |
| 415S120200 | 10 | Withdrawn | |
| 415S120200 | 10 | Withdrawn | |
| 415S120150 | 10 | Withdrawn |
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 |
| 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 |
| PaliumNeedle | M.D.L. S.R.L. | 10 |
Showing 12 of 44. All products under Device, Percutaneous, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080674 | 2008-05-09 |
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.