Temno Evolution®
28 catalogue numbers from 10884450443429, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | Merit Medical Systems, 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-04-16 |
| Record revised | 2025-04-30 (version 3) |
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 | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10884450443429 | Biopsy Device Gauge-20G | 5 | In distribution |
| 10884450443375 | 5 | In distribution | |
| 10884450443597 | Biopsy Device Gauge-18G | 5 | In distribution |
| 10884450443399 | Biopsy Device Gauge-18G | 5 | In distribution |
| 10884450443382 | Biopsy Device Gauge-18G | 5 | In distribution |
| 10884450443368 | Biopsy Device Gauge-16G | 5 | In distribution |
| 10884450443573 | 5 | In distribution | |
| 10884450443566 | Biopsy Device Gauge-16G | 5 | In distribution |
| 10884450443610 | Biopsy Device Gauge-20G | 5 | In distribution |
| 10884450443542 | Biopsy Device Gauge-16G | 5 | In distribution |
| 10884450443412 | Biopsy Device Gauge-20G | 5 | In distribution |
| B | Biopsy Device Gauge-14G | 5 | In distribution |
| 10884450443238 | Biopsy Device Gauge-14G | 5 | In distribution |
| 10884450443603 | Biopsy Device Gauge-18G | 5 | In distribution |
| 10884450443405 | Biopsy Device Gauge-18G | 5 | In distribution |
| 10884450443344 | Coaxial Gauge-13.5G | 5 | In distribution |
| 10884450443474 | Biopsy Device Gauge-14G | 5 | In distribution |
| 10884450443634 | 5 | In distribution | |
| 10884450443467 | 5 | In distribution | |
| 10884450443528 | Biopsy Device Gauge-16G | 5 | In distribution |
| 10884450443627 | Biopsy Device Gauge-20G | 5 | In distribution |
| 10884450443559 | 5 | In distribution | |
| 10884450443641 | 5 | In distribution | |
| 10884450443511 | 5 | In distribution | |
| 10884450443245 | Biopsy Device Gauge-14G | 5 | In distribution |
| 10884450443580 | 5 | In distribution | |
| 10884450443351 | 5 | In distribution | |
| 10884450443498 | 5 | In distribution |
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 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
| SemiCut Coax. | M.D.L. S.R.L. | 22 |
Showing 12 of 115. All products under Biopsy Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151373 | 2015-08-07 |
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.