Integra® Miltex®
Integra® Miltex® Bakes Common Duct Dilator, 8-1/2", Set of 9, Sizes 3mm To 11mm
3manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FGM |
| Device type | Probe And Director, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-16 |
| Record revised | 2025-03-12 (version 8) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-30-SS | In distribution | |
| 1076 | In distribution | |
| 104ST | In distribution | |
| 1072 | In distribution | |
| 10-28-SS | In distribution | |
| 10-4-NS | In distribution | |
| 10-34-SS | In distribution | |
| 14-10-3 | In distribution | |
| 1079 | In distribution | |
| 14-10-7 | In distribution | |
| 102NS | In distribution | |
| 10-38 | In distribution | |
| 1014ST | In distribution | |
| 1012NS | In distribution | |
| 1014NS | In distribution | |
| 10-82 | In distribution | |
| 108NS | In distribution | |
| 14-10-4 | In distribution | |
| 14-8 | In distribution | |
| 1010NS | In distribution | |
| 14-10-5 | In distribution | |
| 14-10-9 | In distribution | |
| 10-22-SS | In distribution | |
| 108ST | In distribution | |
| 10-26-SS | In distribution | |
| 14-10-10 | In distribution | |
| 10-24-SS | In distribution | |
| 102ST | In distribution | |
| 1074 | In distribution | |
| 1012ST | In distribution | |
| 1069 | In distribution | |
| 14-10-6 | In distribution | |
| 14-10-8 | In distribution | |
| 1084 | In distribution | |
| 106ST | In distribution | |
| 1010ST | In distribution | |
| 1070 | In distribution | |
| 10-32-SS | In distribution | |
| 14-10-11 | In distribution | |
| 1080 | In distribution | |
| 106NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 58 |
| Millennium | Avalign Technologies, Inc. | 42 |
| V. Mueller | Steris Corporation | 41 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| HNM Medical | HNM Stainless, LLC. | 14 |
| Universal Probe | Sontec Instruments, Inc. | 11 |
| Peak Medical | Peak Medical Distribution Inc | 8 |
| Aesculap | Aesculap AG | 7 |
| Quinelato | Schobell Industrial Ltda | 7 |
| Grooved Director | Sontec Instruments, Inc. | 7 |
| Hayden Medical | Hayden Medical Inc | 5 |
| Probe With Eye | Sontec Instruments, Inc. | 4 |
Showing 12 of 41. All products under Probe And Director, Gastro-Urology
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.