Temno Elite™
53 catalogue numbers from 00884450397718, listed by Merit Medical Systems, Inc., United States, under Instrument, Biopsy. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
53catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-01-06 |
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 |
| Packaging | Pack of 4, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450397718 | Coaxial Gauge-17G | In distribution |
| 00884450397565 | Biopsy Device Gauge-14G | In distribution |
| 00884450397732 | Coaxial Length (cm)-15.3 cm | In distribution |
| Initial Release | Coaxial Length (cm)-5.3 cm | In distribution |
| 00884450397817 | Biopsy Device Gauge-16G | In distribution |
| 00884450397596 | Biopsy Device Length (cm)-15.0 cm | In distribution |
| 00884450398005 | Coaxial Gauge-17G | In distribution |
| 00884450397923 | Biopsy Device Gauge-20G | In distribution |
| 00884450397992 | Coaxial Gauge-17G | In distribution |
| 00884450398159 | Coaxial Gauge-19G | In distribution |
| 00884450397787 | Biopsy Device Length (cm)-6.0 cm | In distribution |
| 00884450397756 | Biopsy Device Length (cm)-10.0 cm | In distribution |
| 00884450397848 | Biopsy Device Length (cm)-6.0 cm | In distribution |
| 00884450397701 | Coaxial Length (cm)-10.3 cm | In distribution |
| 00884450398050 | Coaxial Gauge-13G | In distribution |
| 00884450398081 | Coaxial Gauge-15G | In distribution |
| 00884450397695 | Biopsy Device Gauge-16G | In distribution |
| 00884450397879 | Biopsy Device Gauge-18G | In distribution |
| 00884450398098 | Coaxial Length (cm)-5.3 cm | In distribution |
| 00884450397725 | Biopsy Device Length (cm)-15.0 cm | In distribution |
| 00884450397572 | Biopsy Device Gauge-14G | In distribution |
| Initial Release | Coaxial Gauge-15G | In distribution |
| 00884450397657 | Biopsy Device Gauge-20G | In distribution |
| Initial Release | Coaxial Gauge-15G | In distribution |
| 00884450397671 | Biopsy Device Length (cm)-10.0 cm | In distribution |
| 00884450397893 | Biopsy Device Length (cm)-6.0 cm | In distribution |
| 00884450398111 | Coaxial Gauge-17G | In distribution |
| 00884450397862 | Biopsy Device Gauge-18G | In distribution |
| 00884450397978 | Coaxial Gauge-15G | In distribution |
| Initial Release | Biopsy Device Gauge-14G | In distribution |
| 00884450398029 | Coaxial Length (cm)-5.4 cm | In distribution |
| 00884450397800 | Biopsy Device Gauge-14G | In distribution |
| 00884450397824 | Biopsy Device Length (cm)-10.0 cm | In distribution |
| 00884450397930 | Biopsy Device Gauge-20G | In distribution |
| 00884450397664 | Coaxial Gauge-19G | In distribution |
| 00884450397855 | Biopsy Device Gauge-18G | In distribution |
| 00884450397763 | Biopsy Device Gauge-20G | In distribution |
| 00884450397831 | Biopsy Device Length (cm)-15.0 cm | In distribution |
| 00884450397954 | Coaxial Length (cm)-10.3 cm | In distribution |
| 00884450398036 | Coaxial Gauge-19G | In distribution |
| 00884450397688 | Biopsy Device Gauge-14G | In distribution |
| 00884450397640 | Biopsy Device Length (cm)-10.0 cm | In distribution |
| 00884450397619 | Biopsy Device Length (cm)-15.0 cm | In distribution |
| 00884450398104 | Coaxial Length (cm)-10.3 cm | In distribution |
| 00884450397770 | Coaxial Length (cm)-15.4 cm | In distribution |
| 00884450397626 | Biopsy Device Gauge-18G | In distribution |
| 00884450397985 | Coaxial Length (cm)-5.3 cm | In distribution |
| 00884450397602 | Coaxial Length (cm)-5.3 cm | In distribution |
| Initial Release | Coaxial Gauge-19G | In distribution |
| 00884450398135 | Coaxial Gauge-19G | In distribution |
| 00884450397909 | Biopsy Device Length (cm)-10.0 cm | In distribution |
| 00884450397589 | Coaxial Gauge-15G | In distribution |
| 00884450398142 | Coaxial Gauge-19G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
Showing 12 of 692. All products under Instrument, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201166 | 2020-08-28 |
| K180450 | 2018-03-12 |
| K153337 | 2016-03-25 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-08-03 | Class II | Process change control | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury. | 2894 |
| 2022-08-03 | Class II | Process change control | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury. | 1822 |
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.