Novapass
Novapass Straight Suture Passer
2manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Jiangsu MJD Medical Technology Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | GEJ |
| Device type | Carrier, Ligature |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2020-12-04 (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. |
| Packaging | Pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G35119 | In distribution | |
| G35121 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| MT | Jiangsu MJD Medical Technology Co., Ltd. | 18 |
| V. Mueller | Steris Corporation | 15 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 5 |
| Marina Medical | Marina Medical Instruments, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 5 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 4 |
| Cygnus | Aspen Surgical Products, Inc. | 4 |
Showing 12 of 35. All products under Carrier, Ligature
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 |
|---|---|---|---|---|---|
| 2017-04-25 | Class II | Labeling design | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | 698 | 2019-03-26 |
| 2017-04-25 | Class II | Labeling design | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | 29 | 2019-03-26 |
| 2017-04-25 | Class II | Labeling design | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | 257 | 2019-03-26 |
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.