Avid TruCustom
16 catalogue numbers from RP1835C_0005, listed by Avid Medical, Inc., United States, under Needle, Conduction, Anesthetic (W/Wo Introducer). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Jiangsu (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 Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Linstant Polymer Materials Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Shanghai SA Medical & Plastic Instruments Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Avid Medical, Inc., United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| 510(k) | K854816 |
| Record published | 2016-09-19 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RP1835C_0005 | In distribution | |
| RP2005RW_0005 | In distribution | |
| RP1735RW_0004 | In distribution | |
| RP2235RW_0006 | In distribution | |
| RP2035RW_0004 | In distribution | |
| RP1835RW_0004 | In distribution | |
| RP1635D_0004 | In distribution | |
| RM2025A_0005 | In distribution | |
| RP1706A_0003 | In distribution | |
| RP1835D_0004 | In distribution | |
| RP1835MRW_0004 | In distribution | |
| RP1806A_0004 | In distribution | |
| RM1705A_0004 | In distribution | |
| RP1705RW_0004 | In distribution | |
| RP1805RW_0004 | In distribution | |
| RP1735P_0004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| Sprotte® | Pajunk Gmbh Medizintechnologie | 273 |
| Avanos | Avanos Medical, Inc. | 264 |
| Epimed | Epimed International, Inc. | 131 |
| Phoenix | DR. Japan Co., Ltd. | 128 |
| Tuohy | Pajunk Gmbh Medizintechnologie | 128 |
| Lccs | Lccs Products Limited | 121 |
| Arrow | Teleflex Medical LLC | 104 |
| Reli | Myco Medical Supplies, Inc. | 86 |
| Sonoblock | Pajunk Gmbh Medizintechnologie | 70 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
Showing 12 of 149. All products under Needle, Conduction, Anesthetic (W/Wo Introducer)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Pain Management | 510(k) number | 2015-05-01 | Class II | Labeling design | Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch). | 123 Tuohy needles | 2015-12-04 |
| Integra Pain Management | 510(k) number | 2015-03-30 | Class II | Employee error | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles. | 90 Tuohy needles (9 cases of 10 each) | 2015-06-24 |
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.