Ranfac Aspiration Needle
The Ranfac Aspiration Needle withdraws bone marrow through a hollow needle. It is a single-use instrument with a stainless steel cannula and stylet, each fitted with a molded plastic…
The Ranfac Aspiration Needle withdraws bone marrow through a hollow needle. It is a single-use instrument with a stainless steel cannula and stylet, each fitted with a molded plastic handle. The handles mate when the stylet is inserted into the cannula.
The clinician rotates the joined needle assembly back and forth while applying pressure to enter the marrow cavity. Once the cavity is reached, the stylet is removed. A syringe attached to the needle applies negative pressure to aspirate the marrow through the cannula.
Listed Item
Ranfac Aspiration Needle, 11 Gauge X 15CM, F/G, Sterile P/N 74062-15M
Syringe Connection
The molded handle incorporates a Luer lock connection for a standard syringe. The syringe is supplied separately. The needle is supplied sterile.
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 | Ranfac Corp., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K131157 |
| Record published | 2017-05-08 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Packaging | Inner pack of 10, case of 8 |
| Sizes | Length 15 cm; needle gauge 11 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11 Gauge X 15CM | Length 15 cm | 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 |
|---|---|
| K223612 | 2023-02-21 |
| K202287 | 2020-09-18 |
| K190177 | 2019-06-12 |
| K183146 | 2019-04-25 |
| K150563 | 2015-05-22 |
| K140991 | 2014-09-11 |
| K131157 | 2013-10-22 |
| K031344 | 2003-05-23 |
| K012224 | 2001-08-22 |
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.