Coaxial Sabd Biopsy Device
13 catalogue numbers from CS-1415-15-T, listed by Argon Medical Devices, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2026-05-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Distribution end date | 2024-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS-1415-15-T | 13ga (2.4mm) x 10.3cm Introducer | Withdrawn |
| CS-2015-15-T | 19ga (1.1mm) x 10.6cm Introducer | Withdrawn |
| CS-1609-15-T | 15ga (1.8mm) x 4.3cm Introducer | Withdrawn |
| CS-1409-15-T | 13ga (2.4mm) x 4.3cm Introducer | Withdrawn |
| CS-1815-15-T | 17ga (1.5mm) x 10.3cm Introducer | Withdrawn |
| CS-1820-15-T | 17ga (1.5mm) x 15.1cm Introducer | Withdrawn |
| CS-2020-15-T | 19ga (1.1mm) x 15.2cm Introducer | Withdrawn |
| CS-2009-15-T | 19ga (1.1mm) x 4.6cm Introducer | Withdrawn |
| CS-1615-15-T | 15ga (1.8mm) x 10.3cm Introducer | Withdrawn |
| CS-2015-15 | 19ga (1.1mm) x 10.6cm Introducer | Withdrawn |
| CS-1815-15 | 17ga (1.5mm) x 10.3cm Introducer | Withdrawn |
| CS-1620-15-T | 15ga (1.8mm) x 14.9cm Introducer | Withdrawn |
| CS-1809-15-T | 17ga (1.5mm) x 4.3cm Introducer | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
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.