Medline
Ndl,whitacre SPINAL,24GX4" NO Introducer
9manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Record published | 2021-01-27 |
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 |
| Storage | Special storage condition: Store at room temperature, out of direct sunlight |
| Packaging | Case of 25, box of 25 |
| Sizes | Length 1.5 to 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PAIN8024 | Length 7 in | In distribution |
| PAIN8023 | Length 5 in | In distribution |
| PAIN8017 | Length 3.5 in | In distribution |
| PAIN8009 | Length 3.5 in | In distribution |
| PAIN8022 | Length 3.5 in | In distribution |
| PAIN8013 | Length 3.5 in | In distribution |
| PAIN8036 | Length 6 in | In distribution |
| PAIN8125 | Length 5 in | In distribution |
| PAIN8025 | Length 5 in | In distribution |
| PAIN8042 | Length 3.5 in | In distribution |
| PAIN8021 | Length 3.5 in | In distribution |
| PAIN8006 | Length 6 in | In distribution |
| PAIN8026 | Length 4 in | In distribution |
| PAIN8007 | Length 5 in | In distribution |
| PAIN8118 | Length 3.5 in | In distribution |
| PAIN8001 | Length 3.5 in | In distribution |
| PAIN8123 | Length 5 in | In distribution |
| PAIN8002 | Length 5 in | In distribution |
| PAIN8014 | Length 5 in | In distribution |
| PAIN8008 | Length 4.5 in | In distribution |
| PAIN8010 | Length 6 in | In distribution |
| PAIN8018 | Length 3.5 in | In distribution |
| PAIN8031 | Length 3.5 in | In distribution |
| PAIN8030 | Length 4 in | In distribution |
| PAIN8011 | Length 1.5 in | In distribution |
| PAIN8027 | Length 2 in | In distribution |
| PAIN8003 | Length 3.5 in | In distribution |
| PAIN8015 | Length 3.5 in | In distribution |
| PAIN8029 | Length 5 in | In distribution |
| PAIN8019 | Length 3.5 in | In distribution |
| PAIN8034 | Length 3.5 in | In distribution |
| PAIN8033 | Length 6 in | In distribution |
| PAIN8016 | Length 2.5 in | In distribution |
| PAIN8005 | Length 3.5 in | In distribution |
| PAIN8032 | Length 5 in | In distribution |
| PAIN8124 | Length 7 in | In distribution |
| PAIN8028 | Length 6 in | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110194 | 2011-06-17 |
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.