Customed
Customed Universal-D Biopsy Needle FOR Bard Magnum With Coaxial Needle, 18G X 250MM, Pink
9manufacturers in China registered for this device type
24catalogue numbers in this listing
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 | Customed, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K092338 |
| Record published | 2016-09-23 |
| Record revised | 2019-07-12 (version 4) |
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 |
| Storage | Special storage condition: Sterile if package is unopened or undamaged.; Special storage condition: Keep in a cool, dry place, away from heat and light sources. |
| Packaging | 10/box of 10, 20/box of 20 |
| Sizes | Length 50 to 250 mm; needle gauge 8 to 21 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 712057839825 | Length 250 mm | In distribution |
| 712057839020 | Length 200 mm | In distribution |
| 712057832116 | Length 160 mm | In distribution |
| 712057831825 | Length 250 mm | In distribution |
| 712057831110 | Length 100 mm | In distribution |
| 712057832120 | Length 200 mm | In distribution |
| 712057831816 | Length 160 mm | In distribution |
| 712057838020 | Length 200 mm | In distribution |
| 712057837016 | Length 160 mm | In distribution |
| 712057831650 | Length 50 mm | In distribution |
| 712057830815 | Length 150 mm | In distribution |
| 712057839016 | Length 160 mm | In distribution |
| 712057838016 | Length 160 mm | In distribution |
| 712057832020 | Length 200 mm | In distribution |
| 712057839816 | Length 160 mm | In distribution |
| 712057831716 | Length 160 mm | In distribution |
| 712057831812 | Length 120 mm | In distribution |
| 712057830810 | Length 100 mm | In distribution |
| 712057831820 | Length 200 mm | In distribution |
| 712057839116 | Length 160 mm | In distribution |
| 712057837020 | Length 200 mm | In distribution |
| 712057839812 | Length 120 mm | In distribution |
| 712057831115 | Length 150 mm | In distribution |
| 712057831660 | Length 60 mm | 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
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.