Centeze Centesis Catheter
8 catalogue numbers from DRC-002-05, listed by Galt Medical Corp., United States, under Accessories, Catheter. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
8catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter
Record
| Listed by | Galt Medical Corp., United States |
|---|---|
| FDA product code | KGZ |
| Device type | Accessories, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-03-20 |
| Record revised | 2022-03-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Shipper box of 100, shelf box of 10 |
| Sizes | Catheter gauge 4 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRC-002-05 | Catheter Gauge 5 Fr | In distribution |
| DRC-002-08 | Catheter Gauge 5 Fr | In distribution |
| DRC-002-07 | Catheter Gauge 4 Fr | In distribution |
| DRC-002-02 | Catheter Gauge 5 Fr | In distribution |
| DRC-002-01 | Catheter Gauge 4 Fr | In distribution |
| DRC-009-00 | Catheter Gauge 5 Fr | In distribution |
| DRC-002-06 | Catheter Gauge 6 Fr | In distribution |
| DRC-002-04 | Catheter Gauge 4 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedDrain | Armm, Inc. | 77 |
| Silicone Drainage Tube | Fortune Medical Instrument Corp. | 74 |
| Typenex Wound Drainage | Typenex Medical, LLC | 56 |
| Cook | Cook Incorporated | 49 |
| Marina Medical | Marina Medical Instruments, Inc. | 48 |
| Curaplex | Bound Tree Medical, LLC | 36 |
| Mediplus | Mediplus Ltd. | 29 |
| AlliedSil™ Silicone Tubing | Implantech Associates, Inc. | 24 |
| Arrow | Teleflex Medical LLC | 23 |
| Silicone Thoracic Catheters | Atrium Medical Corporation | 21 |
| Neff | Cook Incorporated | 18 |
| Silhouette | Cook Incorporated | 16 |
Showing 12 of 111. All products under Accessories, Catheter
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Galt Medical Corp. | UDI-DI | 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 2,881 catheters |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-11-16 | Class II | Process control | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. | 9,920 catheters (updated on 03/17/2021) | 2022-11-07 |
| 2018-05-02 | Class II | Other | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever | 3530 | 2020-07-20 |
| 2018-05-02 | Class II | Other | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever | 300 | 2020-07-20 |
| 2018-05-02 | Class II | Other | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever | 13210 | 2020-07-20 |
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.