Arrow
SureBlock(TM) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose and Sharps Safety Features
9manufacturers in China registered for this device type
104catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K911260 |
| Record published | 2016-09-16 |
| Record revised | 2021-09-03 (version 8) |
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, manufacturing date |
| Storage | Special storage condition: Avoid freezing and excessive heat above 40°C (104°F).; Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, box of 5, case of 25, multipack of 25, box of 25, pack of 5 |
| Sizes | Length 2.5 to 10.3 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN045634 | In distribution | |
| IPN915660 | In distribution | |
| IPN040073 | In distribution | |
| IPN045597 | In distribution | |
| IPN040081 | In distribution | |
| IPN040068 | In distribution | |
| IPN040082 | Length 9 cm | In distribution |
| IPN045625 | Length 9 cm | In distribution |
| IPN045627 | Length 9 cm | In distribution |
| IPN928603 | In distribution | |
| IPN045759 | Length 9 cm | In distribution |
| IPN045624 | In distribution | |
| IPN045632 | Length 9 cm | In distribution |
| IPN040076 | Length 10.3 cm | In distribution |
| IPN040081 | In distribution | |
| IPN915659 | In distribution | |
| IPN923597 | In distribution | |
| IPN045635 | Length 9 cm | In distribution |
| IPN045600 | In distribution | |
| IPN045625 | Length 9 cm | In distribution |
| IPN040088 | Length 9 cm | In distribution |
| IPN040076 | Length 10.3 cm | In distribution |
| IPN915661 | In distribution | |
| IPN040070 | Length 9 cm | In distribution |
| IPN040071 | In distribution | |
| IPN040080 | In distribution | |
| IPN916801 | In distribution | |
| IPN922607 | In distribution | |
| IPN040090 | In distribution | |
| IPN928612 | In distribution | |
| IPN922602 | In distribution | |
| IPN048001 | In distribution | |
| IPN040065 | In distribution | |
| IPN040086 | In distribution | |
| IPN045758 | In distribution | |
| IPN040074 | In distribution | |
| IPN928605 | In distribution | |
| IPN915658 | In distribution | |
| IPN919976 | In distribution | |
| IPN040083 | In distribution | |
| IPN040075 | In distribution | |
| IPN045627 | Length 9 cm | In distribution |
| IPN928607 | In distribution | |
| IPN916800 | In distribution | |
| IPN040072 | Length 9 cm | In distribution |
| IPN045633 | Length 9 cm | In distribution |
| IPN045635 | Length 9 cm | In distribution |
| IPN040089 | In distribution | |
| IPN045629 | Length 10.3 cm | In distribution |
| IPN928615 | In distribution | |
| IPN922603 | In distribution | |
| IPN045635 | Length 9 cm | In distribution |
| IPN045631 | In distribution | |
| IPN040067 | In distribution | |
| IPN045630 | In distribution | |
| IPN040069 | In distribution | |
| IPN922631 | In distribution | |
| IPN040064 | Length 9 cm | In distribution |
| IPN040078 | Length 10.3 cm | In distribution |
| IPN045629 | Length 10.3 cm | In distribution |
| IPN040064 | Length 9 cm | In distribution |
| IPN919977 | In distribution | |
| IPN045627 | Length 9 cm | In distribution |
| IPN045628 | In distribution | |
| IPN045759 | In distribution | |
| IPN922606 | In distribution | |
| IPN040087 | In distribution | |
| IPN040069 | In distribution | |
| IPN040091 | In distribution | |
| IPN055746 | In distribution | |
| IPN045625 | Length 9 cm | In distribution |
| IPN040083 | In distribution | |
| IPN045633 | Length 9 cm | In distribution |
| IPN045632 | Length 9 cm | In distribution |
| IPN040087 | In distribution | |
| IPN048002 | In distribution | |
| IPN045636 | Length 9 cm | In distribution |
| IPN045758 | In distribution | |
| IPN045599 | Length 2.5 cm | In distribution |
| IPN045632 | Length 9 cm | In distribution |
| IPN040075 | In distribution | |
| IPN040065 | In distribution | |
| IPN928613 | In distribution | |
| IPN922632 | In distribution | |
| IPN040091 | In distribution | |
| IPN922604 | In distribution | |
| IPN040077 | In distribution | |
| IPN040086 | In distribution | |
| IPN928608 | In distribution | |
| IPN045601 | Length 5 cm | In distribution |
| IPN040068 | In distribution | |
| IPN045629 | Length 10.3 cm | In distribution |
| IPN040079 | In distribution | |
| IPN040088 | Length 9 cm | In distribution |
| IPN045626 | In distribution | |
| IPN040074 | In distribution | |
| IPN922622 | In distribution | |
| IPN040066 | Length 9 cm | In distribution |
| IPN040080 | In distribution | |
| IPN045633 | Length 9 cm | In distribution |
| IPN040070 | Length 9 cm | In distribution |
| IPN040082 | Length 9 cm | In distribution |
| IPN040077 | In distribution | |
| IPN922605 | 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 |
| Reli | Myco Medical Supplies, Inc. | 86 |
| Sonoblock | Pajunk Gmbh Medizintechnologie | 70 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
| Spinal Needle | Hakko Co., Ltd. | 51 |
Showing 12 of 149. All products under Needle, Conduction, Anesthetic (W/Wo Introducer)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190026 | 2019-08-21 |
| K173321 | 2018-04-25 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 79,614 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-20 | Class II | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product | 90 | 2021-02-25 |
| Teleflex Medical LLC | 510(k) number | 2019-10-11 | Class II | Process control | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches | 4227 devices | |
| Teleflex Medical LLC | 510(k) number | 2019-10-11 | Class II | Process control | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches | 800 devices | |
| Pajunk Gmbh Medizintechnologie | 510(k) number | 2019-08-30 | Class II | Process control | Problem with packaging sealing process which affects sterility. | 40,475 devices |
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.