NRG Large Access Solution
1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip Guidewire); 1 x ProTrack Pigtail Wire; 1 x Dispersive Electrode
13manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Baylis Médicale Cie Inc |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Record published | 2020-04-08 |
| Record revised | 2023-12-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NLK-71-C0-125-67-23 | 71cm Standard Curve C0 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in); 230cm ProTrack Pigtail Wire | Withdrawn |
| NLK-71-C0-125-67 | 71cm Standard Curve C0 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in) | Withdrawn |
| NLK-71-C1-125-67-23 | 71cm Large Curve C1 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in); 230cm ProTrack Pigtail Wire | Withdrawn |
| NLK-71-C0-125-67-18 | 71cm Standard Curve C0 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in); 175cm ProTrack Pigtail Wire | Withdrawn |
| NLK-71-C1-125-67 | 71cm Large Curve C1 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in) | Withdrawn |
| NLK-71-C1-125-67-18 | 71cm Large Curve C1 NRG Transseptal Needle; 12.5F 67cm ExpanSure Large Access Transseptal Dilator with 70° Curve (including 180cm J-tip Guidewire with OD = 0.032in); 175cm ProTrack Pigtail Wire | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
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.