Integra® Miltex®
Integra® Miltex® Van Buren Urethral Sounds, 10-3/4", Set Of 12, 8 Fr. Thru 30 Fr., Khaki Roll
1manufacturer
105catalogue 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 | 2018-08-20 |
| Record revised | 2024-11-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Catheter gauge 8 to 38 Fr; length 6 in |
| Distribution end date | 2022-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MH29-6-22 | In distribution | |
| 29-33-36 | Catheter Gauge 36 Fr | In distribution |
| 29-14-12 | In distribution | |
| 29-18-28 | 11-1/4″ | In distribution |
| 29-6-8 | 10-3/4″ | In distribution |
| 29-8-18 | In distribution | |
| 29-4 | In distribution | |
| 29-33-16 | Catheter Gauge 16 Fr | In distribution |
| 29-6-10 | 10-3/4″ | In distribution |
| 29-14-8 | In distribution | |
| 29-8-24 | In distribution | |
| 29-18-20 | 11-1/4″ | In distribution |
| 29-6-34 | In distribution | |
| 29-10-16 | In distribution | |
| 29-14-20 | In distribution | |
| MH29-6-18 | In distribution | |
| 29-10-24 | In distribution | |
| 29-14-30 | In distribution | |
| 29-14-22 | In distribution | |
| 29-32-16 | 5-7/8″ | In distribution |
| 29-6-18 | Catheter Gauge 18 Fr | In distribution |
| 29-8-28 | In distribution | |
| MH29-6-20 | In distribution | |
| 29-6-36 | In distribution | |
| 29-8-30 | In distribution | |
| 29-33-18 | Catheter Gauge 18 Fr | In distribution |
| 29-10-22 | In distribution | |
| 29-6-26 | Catheter Gauge 26 Fr | In distribution |
| 29-10-10 | In distribution | |
| 29-10-14 | In distribution | |
| 29-14-28 | In distribution | |
| MH29-6-16 | In distribution | |
| 29-14-10 | In distribution | |
| 29-8-22 | In distribution | |
| 29-10-26 | In distribution | |
| 29-14-18 | In distribution | |
| MH29-6-34 | In distribution | |
| 29-32-14 | Catheter Gauge 14 Fr | In distribution |
| 29-10-18 | In distribution | |
| 29-14-26 | In distribution | |
| MH29-6-36 | In distribution | |
| 29-8-26 | In distribution | |
| 29-6-14 | 10-3/4″ | In distribution |
| 29-6-12 | Catheter Gauge 12 Fr | In distribution |
| 29-33-22 | Catheter Gauge 22 Fr | In distribution |
| 29-33-26 | 5-1/2″ | In distribution |
| 29-14-34 | In distribution | |
| 29-6-22 | Catheter Gauge 22 Fr | In distribution |
| MH29-6-28 | In distribution | |
| 29-33-28 | Catheter Gauge 28 Fr | In distribution |
| MH29-6-14 | In distribution | |
| 29-32-10 | 5-7/8″ | In distribution |
| 29-14-16 | In distribution | |
| 29-18-22 | 11-1/4″ | In distribution |
| 29-33-14 | 5-1/4″ | In distribution |
| 29-10-30 | In distribution | |
| 29-8-32 | In distribution | |
| MH29-6-8 | In distribution | |
| 29-8-8 | In distribution | |
| 29-8-10 | In distribution | |
| 29-2 | In distribution | |
| 29-6-40 | In distribution | |
| 29-33-24 | Catheter Gauge 24 Fr | In distribution |
| 29-33-34 | Catheter Gauge 34 Fr | In distribution |
| 29-6-24 | Catheter Gauge 24 Fr | In distribution |
| 29-14-36 | In distribution | |
| MH29-6-26 | In distribution | |
| 29-6-38 | In distribution | |
| 29-33-38 | Catheter Gauge 38 Fr | In distribution |
| 29-14-14 | In distribution | |
| 29-18-30 | Catheter Gauge 30 Fr | In distribution |
| MH29-6-30 | In distribution | |
| 29-14-24 | In distribution | |
| 29-18-24 | Catheter Gauge 24 Fr | In distribution |
| 29-18-18 | Catheter Gauge 18 Fr | In distribution |
| MH29-6-24 | In distribution | |
| MH29-6-10 | In distribution | |
| 29-32-8 | 5-7/8″ | In distribution |
| 29-8-16 | In distribution | |
| 29-10-28 | In distribution | |
| 29-33-32 | 5-3/4″ | In distribution |
| 29-18-34 | 11-1/4″ | In distribution |
| MH29-6-32 | In distribution | |
| 29-10-12 | In distribution | |
| 29-14-32 | In distribution | |
| 29-8-12 | In distribution | |
| 29-8-14 | In distribution | |
| MH29-6-12 | In distribution | |
| 29-33-12 | Catheter Gauge 12 Fr | In distribution |
| 29-33-20 | 5-3/8″ | In distribution |
| 29-6-32 | In distribution | |
| 29-6-28 | Catheter Gauge 28 Fr | In distribution |
| 29-18-32 | 11-1/4″ | In distribution |
| 29-18-16 | Catheter Gauge 16 Fr | In distribution |
| 29-6-16 | 10-3/4″ | In distribution |
| 29-32-12 | Catheter Gauge 12 Fr | In distribution |
| 29-6-20 | 10-3/4″ | In distribution |
| 29-10-20 | In distribution | |
| 29-6-30 | Catheter Gauge 30 Fr | In distribution |
| 29-8-34 | In distribution | |
| 29-18-26 | Catheter Gauge 26 Fr | In distribution |
| 29-8-20 | In distribution | |
| 29-32-18 | Catheter Gauge 18 Fr | In distribution |
| 29-33-30 | Catheter Gauge 30 Fr | In distribution |
| 29-18-36 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 204 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 165 |
| Hayden Medical | Hayden Medical Inc | 105 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 95 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 87 |
| 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.