Cook
Yueh Centesis Disposable Catheter Needle
7manufacturers in China registered for this device type
17catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Jiangsu Yangtze River Medical Technology Corp. | Taizhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | GCB |
| Device type | Needle, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G09492 | In distribution | |
| G09491 | In distribution | |
| G55530 | In distribution | |
| G12892 | In distribution | |
| G56317 | In distribution | |
| G09490 | In distribution | |
| G56319 | In distribution | |
| G09646 | In distribution | |
| G10474 | In distribution | |
| G12996 | In distribution | |
| G08064 | In distribution | |
| G10100 | In distribution | |
| G55529 | In distribution | |
| G56318 | In distribution | |
| G55528 | In distribution | |
| G09488 | In distribution | |
| G09489 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MAK-NV™ | Merit Medical Systems, Inc. | 26 |
| Ring-McLean | Cook Incorporated | 16 |
| Jet-Vac Procedure Trays | PFM Medical, Inc | 16 |
| Accel® | B. Braun Medical Inc. | 12 |
| Access Needle | Mermaid Medical A/S | 11 |
| Teleflex | Teleflex Medical LLC | 8 |
| Ring | Cook Incorporated | 7 |
| M-Drain Centesis Catheter | Mermaid Medical A/S | 6 |
| Accel™ | B. Braun Interventional Systems, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 4 |
| Accel Centesis Catheter | PFM Medical, Inc | 4 |
| Skater™ Introducer System | Argon Medical Devices, Inc. | 3 |
Showing 12 of 30. All products under Needle, 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 |
|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 296 units |
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.