Integra® Miltex®
Integra® Miltex® Buie Fistula Probe, 5-3/8" Working Length, 1.5mm Tip, Light, Silver
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EXX |
| Device type | Probe, Rectal, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-10 |
| Record revised | 2025-03-12 (version 7) |
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 |
| Sizes | Length 6 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-108 | In distribution | |
| 28-109 | Length 6 in | In distribution |
| 28-104 | In distribution | |
| 28-106 | 1.5mm Tip | In distribution |
| 28-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marina Medical | Marina Medical Instruments, Inc. | 12 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 9 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 8 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 6 |
| Novo Surgical | Novo Surgical, Inc. | 6 |
| Aesculap | Aesculap AG | 6 |
| V. Mueller | Steris Corporation | 4 |
| Millennium | Avalign Technologies, Inc. | 2 |
| Gimmi | Gimmi Gmbh | 2 |
| BR Surgical, LLC | BR Surgical LLC | 1 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
| GreenEgg | Endoglow, LLC | 1 |
Showing 12 of 14. All products under Probe, Rectal, Non-Powered
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.