Ross
Ross Modified Transseptal Needle
9manufacturers in China registered for this device type
4catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|
| G31154 | In distribution | |
| G31155 | In distribution | |
| G31157 | In distribution | |
| G31193 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 107 |
| Trocar | Doppkon Gmbh & Co. KG | 53 |
| Merit Advance® | Merit Medical Systems, Inc. | 39 |
| HeartSpan® | Merit Medical | 29 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 22 |
| Argyle | Cardinal Health | 20 |
| Apple-Hunt Secondary Cannula | Coopersurgical, Inc. | 20 |
| HeartSpan® | Merit Medical Systems, Inc. | 16 |
| AngioDynamics | AngioDynamics, Inc. | 16 |
| Majestik® | Merit Medical Systems, Inc. | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
Showing 12 of 57. All products under Trocar
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 55 units | |
| 2021-10-08 | Class II | Nonconforming Material/Component | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactio | 31,502 US (30,166 OUS) | 2024-02-14 |
| 2019-02-01 | Class I | Process control | The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion. | 100 | 2020-06-30 |
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.