Integra® Miltex®
Integra® Miltex® Perkins Endaural Retractor 4-7/8", Left-3 Semi-Sharp Prongs, Right- Serrated Solid Blade
3manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (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 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2024-06-25 (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 |
| Sizes | Width 7.5 to 20 mm; length 15.5 to 20 mm; length 4 to 7 in; outer diameter 2.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22-856 | In distribution | |
| 11-617 | In distribution | |
| 22-854 | In distribution | |
| 20-838 | Width 20 mm | In distribution |
| 20-835 | In distribution | |
| 19-668 | In distribution | |
| 11-600 | In distribution | |
| 11-608 | In distribution | |
| MH22-854 | In distribution | |
| 19-660 | In distribution | |
| 22-890 | 8-1/4″ | In distribution |
| 23-1049 | In distribution | |
| 19-655 | In distribution | |
| 20-836 | 3-7/8″ Working Length | In distribution |
| 11-6 | 4X4 Sharp Prongs | In distribution |
| 11-616 | In distribution | |
| 11-618 | In distribution | |
| 11-614 | In distribution | |
| 11-610 | In distribution | |
| 19-669 | In distribution | |
| 11-602 | In distribution | |
| MH23-1049 | In distribution | |
| 11-622 | In distribution | |
| 23-1047 | Length 7 in | In distribution |
| MH11-22 | In distribution | |
| 11-620 | In distribution | |
| MH11-2 | 2-1/8″ Spread | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
Showing 12 of 80. All products under Retractor, Ent
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.