Integra® Jarit®
Integra® Jarit® Walther Female Dilator-Catheter, 5-3/4", 34 French
1manufacturer
87catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FBX |
| Device type | Sound, Urethral, Metal Or Plastic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-16 |
| Record revised | 2024-11-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No |
| Sizes | Catheter gauge 8 to 38 Fr; length 6 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X304445 | Catheter Gauge 34 Fr | In distribution |
| 475556 | In distribution | |
| X302121 | In distribution | |
| 475550 | In distribution | |
| 475551 | In distribution | |
| X304425 | 5-1/4″ | In distribution |
| X30921 | In distribution | |
| 475563 | In distribution | |
| X304447 | Catheter Gauge 36 Fr | In distribution |
| 475-538 | In distribution | |
| 475559 | In distribution | |
| X302933 | 11-1/4″ | In distribution |
| X302123 | In distribution | |
| 475-544 | In distribution | |
| X304427 | 5-1/4″ | In distribution |
| 475-545 | In distribution | |
| X30749 | In distribution | |
| X302141 | In distribution | |
| X302133 | In distribution | |
| 475561 | In distribution | |
| X304449 | Catheter Gauge 38 Fr | In distribution |
| X304435 | Catheter Gauge 24 Fr | In distribution |
| X302927 | 11-1/4″ | In distribution |
| X304443 | Catheter Gauge 32 Fr | In distribution |
| X304441 | 5-5/8″ | In distribution |
| X302139 | In distribution | |
| X30751 | In distribution | |
| X302135 | In distribution | |
| X30941 | 11-1/2″ | In distribution |
| 475635 | 5-7/8″ | In distribution |
| X302935 | Catheter Gauge 24 Fr | In distribution |
| 475558 | In distribution | |
| X302127 | In distribution | |
| X30933 | In distribution | |
| 475552 | In distribution | |
| 475-535 | In distribution | |
| X302945 | 11-1/4″ | In distribution |
| X30943 | 11-1/2″ | In distribution |
| 475-537 | In distribution | |
| 475-540 | In distribution | |
| X302129 | In distribution | |
| 475-547 | In distribution | |
| X302131 | In distribution | |
| 475-539 | In distribution | |
| 475560 | In distribution | |
| X302137 | In distribution | |
| X302931 | 11-1/4″ | In distribution |
| 475-548 | In distribution | |
| X30927 | In distribution | |
| 475557 | In distribution | |
| X304429 | Catheter Gauge 18 Fr | In distribution |
| X304439 | Catheter Gauge 28 Fr | In distribution |
| X3099 | 11-1/2″ | In distribution |
| X30925 | In distribution | |
| 475554 | In distribution | |
| 475634 | 5-7/8″ | In distribution |
| 475555 | In distribution | |
| X304423 | 5-1/4″ | In distribution |
| X30945 | 11-1/2″ | In distribution |
| 475636 | Catheter Gauge 16 Fr | In distribution |
| X304437 | 5-1/2″ | In distribution |
| X30923 | In distribution | |
| 475-543 | In distribution | |
| X30929 | In distribution | |
| 475637 | 5-7/8″ | In distribution |
| 475562 | In distribution | |
| X302941 | 11-1/4″ | In distribution |
| X302125 | In distribution | |
| X302929 | Catheter Gauge 28 Fr | In distribution |
| X304321 | Catheter Gauge 10 Fr | In distribution |
| 475553 | In distribution | |
| 475-536 | In distribution | |
| 475-542 | In distribution | |
| X30937 | 11-1/2″ | In distribution |
| X302943 | 11-1/4″ | In distribution |
| X30931 | In distribution | |
| X30439 | 5-7/8″ | In distribution |
| X302939 | 11-1/4″ | In distribution |
| X304433 | 5-3/8″ | In distribution |
| X30939 | 11-1/2″ | In distribution |
| X302937 | 11-1/4″ | In distribution |
| 475-541 | In distribution | |
| 475-549 | In distribution | |
| 475-546 | In distribution | |
| X304431 | 5-3/8″ | In distribution |
| X30935 | 11-1/2″ | In distribution |
| 475564 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 204 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 165 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 105 |
| Hayden Medical | Hayden Medical Inc | 105 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 95 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 82 |
| V. Mueller | Steris Corporation | 73 |
| BR Surgical, LLC | BR Surgical LLC | 70 |
| Aesculap | Aesculap AG | 63 |
| HNM Medical | HNM Stainless, LLC. | 54 |
| Novo Surgical | Novo Surgical, Inc. | 45 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 21 |
Showing 12 of 33. All products under Sound, Urethral, Metal Or Plastic
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.