OptiSeal™
Valved PTFE Peelable Introducer NSP
13manufacturers in China registered for this device type
127catalogue numbers in this listing
16recalls on this code
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 | Greatbatch Medical, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-08-15 |
| Record revised | 2024-03-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature up to 40 °C |
| Packaging | Box of 5, pack of 5, box |
| Sizes | Length 13 to 60 cm; lumen/inner diameter 0.89 to 4.2 mm; catheter gauge 6 to 12 Fr; total volume 12 ml; needle gauge 18 G; outer diameter 0.89 mm; guidewire length 60 cm; lumen/inner diameter 2.8 to 25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000093-026 | Sheath Effective Length: 25 cm | In distribution |
| 1000093-020 | Guidewire Length 60 cm | In distribution |
| 1002634-013 | Lumen/Inner Diameter 3.8 mm | In distribution |
| 1002633-009 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 1000092-008 | Total Volume 12 ml | In distribution |
| 1002633-008 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 1000093-016 | Catheter Gauge 7 Fr | In distribution |
| 1000093-005 | Total Volume 12 ml | In distribution |
| 1003975-007 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-011 | Lumen/Inner Diameter 3.2 mm | In distribution |
| 1000093-012 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-010 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-003 | Dilator OD: 2.9 mm | In distribution |
| 1003975-004 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-004 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-024 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-001 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-014 | Total Volume 12 ml | In distribution |
| 1003975-014 | Total Volume 12 ml | In distribution |
| 1000093-015 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-006 | Total Volume 12 ml | In distribution |
| 1002634-005 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1000093-012 | Total Volume 12 ml | In distribution |
| 1002634-011 | Lumen/Inner Diameter 3.2 mm | In distribution |
| 1000093-028 | Syringe Total Volume: 12 milliliter | In distribution |
| 1003975-005 | Total Volume 12 ml | In distribution |
| 1002634-001 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 1003975-009 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-025 | Syringe Total Volume: 12 milliliter | In distribution |
| 1003975-010 | Total Volume 12 ml | In distribution |
| 1000093-022 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-004 | Lumen/Inner Diameter 3.2 mm | In distribution |
| 1003975-005 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-005 | Total Volume 12 ml | In distribution |
| 1002634-004 | Lumen/Inner Diameter 3.2 mm | In distribution |
| 1002634-008 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 1003975-001 | Sheath ID: 2.1 mm | In distribution |
| 1000093-003 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-002 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 1000092-002 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002634-010 | Lumen/Inner Diameter 2.8 mm | In distribution |
| 1000093-021 | Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm | In distribution |
| 1000093-017 | Catheter Gauge 8 Fr | In distribution |
| 1000093-008 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002634-012 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1002633-003 | Lumen/Inner Diameter 2.8 mm | In distribution |
| 1002634-009 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 1000093-013 | Total Volume 12 ml | In distribution |
| 1003975-002 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-009 | Total Volume 12 ml | In distribution |
| 1003975-006 | Total Volume 12 ml | In distribution |
| 1003975-002 | Total Volume 12 ml | In distribution |
| 1002633-006 | Lumen/Inner Diameter 3.8 mm | In distribution |
| 1000093-023 | Sheath Effective Length: 25 cm | In distribution |
| 1003975-014 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-019 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-010 | Total Volume 12 ml | In distribution |
| 1000093-026 | Catheter Gauge 10 Fr | In distribution |
| 1000093-005 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002634-014 | Lumen/Inner Diameter 4.2 mm | In distribution |
| 1000093-025 | Guidewire Length 60 cm | In distribution |
| 1003975-004 | Total Volume 12 ml | In distribution |
| 1000093-006 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-016 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-007 | Total Volume 12 ml | In distribution |
| 1000093-007 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-009 | Total Volume 12 ml | In distribution |
| 1000093-014 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-001 | Total Volume 12 ml | In distribution |
| 1000093-020 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-002 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-027 | Catheter Gauge 11 Fr | In distribution |
| 1000092-006 | Total Volume 12 ml | In distribution |
| 1000092-001 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-001 | Total Volume 12 ml | In distribution |
| 1000093-017 | Syringe Total Volume: 12 milliliter | In distribution |
| 1003975-013 | Length 25 cm | In distribution |
| 1000093-009 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-013 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-021 | Catheter Gauge 12 Fr | In distribution |
| 1003975-001 | Total Volume 12 ml | In distribution |
| 1000092-013 | Total Volume 12 ml | In distribution |
| 1000093-018 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-005 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1003975-003 | Total Volume 12 ml | In distribution |
| 1002633-001 | Lumen/Inner Diameter 2.2 mm | In distribution |
| 1000093-019 | Catheter Gauge 10 Fr | In distribution |
| 1003975-013 | Guidewire Length: 60 cm | In distribution |
| 1000092-002 | Total Volume 12 ml | In distribution |
| 1003975-008 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-011 | Total Volume 12 ml | In distribution |
| 1003975-012 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-014 | Lumen/Inner Diameter 4.2 mm | In distribution |
| 1000093-015 | Catheter Gauge 6 Fr | In distribution |
| 1002634-003 | Lumen/Inner Diameter 2.8 mm | In distribution |
| 1002633-013 | Lumen/Inner Diameter 3.8 mm | In distribution |
| 1000093-004 | Syringe Total Volume: 12 milliliter | In distribution |
| 1003975-003 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000092-007 | Total Volume 12 ml | In distribution |
| 1003975-012 | Total Volume 12 ml | In distribution |
| 1000093-011 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-002 | Total Volume 12 ml | In distribution |
| 1000093-008 | Total Volume 12 ml | In distribution |
| 1000093-027 | Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm | In distribution |
| 1002633-007 | Lumen/Inner Diameter 4.2 mm | In distribution |
| 1000092-003 | Total Volume 12 ml | In distribution |
| 1002634-007 | Lumen/Inner Diameter 4.2 mm | In distribution |
| 1002633-012 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1000093-018 | Catheter Gauge 9 Fr | In distribution |
| 1000093-004 | Total Volume 12 ml | In distribution |
| 1002634-002 | Lumen/Inner Diameter 2.5 mm | In distribution |
| 1003975-011 | Total Volume 12 ml | In distribution |
| 1003975-011 | Syringe Total Volume: 12 milliliter | In distribution |
| 1002633-010 | Lumen/Inner Diameter 2.8 mm | In distribution |
| 1003975-009 | Total Volume 12 ml | In distribution |
| 1003975-008 | Total Volume 12 ml | In distribution |
| 1000092-011 | Total Volume 12 ml | In distribution |
| 1000093-010 | Total Volume 12 ml | In distribution |
| 1002634-006 | Lumen/Inner Diameter 3.8 mm | In distribution |
| 1000092-012 | Total Volume 12 ml | In distribution |
| 1003975-010 | Syringe Total Volume: 12 milliliter | In distribution |
| 1000093-022 | Catheter Gauge 6 Fr | In distribution |
| 1003975-006 | Syringe Total Volume: 12 milliliter | In distribution |
| 1003975-007 | Total Volume 12 ml | In distribution |
| 1000093-023 | Catheter Gauge 7 Fr | In distribution |
| 1000092-004 | Total Volume 12 ml | In distribution |
| 1000093-024 | Catheter Gauge 8 Fr | In distribution |
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 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
| Tearaway Introducer Set | Galt Medical Corp. | 96 |
Showing 12 of 439. All products under Introducer, Catheter
Recalls
7 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 |
|---|---|---|---|---|---|
| 2017-02-15 | Class II | Process control | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. | 11,360 | 2019-05-09 |
| 2016-11-11 | Class II | Process control | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. | 5,000 devices | 2017-11-03 |
| 2016-09-08 | Class II | Process design | Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use. | 23,075 | 2017-09-08 |
| 2014-04-28 | Class II | Incorrect or no expiration date | Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set. | 6,642 sets (66,420 devices) | 2016-05-24 |
| 2013-05-31 | Class II | Process control | Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the gui | 550 kits (OUS) | 2014-08-04 |
| 2012-11-12 | Class II | Nonconforming Material/Component | Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion ( | 10,201 units | 2014-05-15 |
| 2012-09-24 | Class II | Device Design | We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters “self-advancing” whi | 9040 | 2014-05-15 |
| 2010-07-02 | Not classified | Packaging | The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infecti | 211 5-pack boxes | 2011-12-17 |
| 2005-08-31 | Not classified | Other | Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole. | 140 | 2006-07-22 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 281 boxes | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 20 units | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 14 units | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 601 boxes | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 955 boxes | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 11 boxes | 2004-07-02 |
| 2003-06-06 | Not classified | Other | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | 2004-07-02 |
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.