Majestik®
14 catalogue numbers from 00884450008638, listed by Merit Medical Systems, Inc., United States, under Trocar. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-04-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450008638 | Length (cm)-7.0 cm | In distribution |
| 00884450008676 | Length (cm)-5.1 cm | In distribution |
| 00884450012024 | Gauge-18G | In distribution |
| 00884450008706 | Gauge-19G | In distribution |
| 00884450008652 | Length (cm)-5.1 cm | In distribution |
| 00884450008621 | Accepts Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450008584 | Length (cm)-5.1 cm | In distribution |
| 00884450016930 | Gauge-18G | In distribution |
| 00884450008669 | Length (cm)-7.0 cm | In distribution |
| 00884450008591 | Gauge-18G | In distribution |
| 00884450008553 | Length (cm)-7.0 cm | In distribution |
| 00884450008645 | Accepts Guide Wire-0.038″ (0.97 mm) | In distribution |
| 00884450012291 | Length (cm)-5.1 cm | In distribution |
| 00884450016947 | Length (cm)-7.0 cm | 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 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
| PathBuilder Transseptal Needle | Shanghai Microport EP Medtech Co., Ltd. | 8 |
Showing 12 of 57. All products under Trocar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K022117 | 2002-10-11 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2021-01-19 | Class II | Process control | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to | 587 Units | 2022-05-17 |
| 2021-01-19 | Class II | Process control | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to | 448 Units | 2022-05-17 |
| 2016-03-15 | Class II | Software design | Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX” Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on | 25 | 2016-08-22 |
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.