Integra® Miltex®
Integra® Miltex® Hudson Cerebellar Extension, 3-7/8", For Braces, REF # 26-32, 26-35
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Guangdong (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 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HBD |
| Device type | Handpiece (Brace), Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4325 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-04-27 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 26-35 | In distribution | |
| 26-32 | In distribution | |
| 26-24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
| Aesculap | Aesculap AG | 2 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Symmetry Bunnell | Aspen Surgical Products, Inc. | 1 |
| Macro-Line | Aesculap AG | 1 |
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.