Integra®
Integra® University of Minnesota Cheek Retractor and Tongue Depressor
3manufacturers in China registered for this device type
19catalogue 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 | 2018-09-17 |
| Record revised | 2025-02-03 (version 4) |
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, manufacturing date |
| Sizes | Width 11.5 to 31 mm; length 7 in; length 110 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3714192 | In distribution | |
| 3714180 | 7-3/4″ | In distribution |
| 3714193 | In distribution | |
| 3714033 | 5-3/4″ | In distribution |
| 3714031 | In distribution | |
| 3714181 | 6-1/4″ | In distribution |
| 3714178 | Width 31 mm | In distribution |
| 3734091 | In distribution | |
| 3734047 | In distribution | |
| 3714018 | In distribution | |
| 3714452 | Width 11.5 mm | In distribution |
| 3714451 | Length 7 in | In distribution |
| 3714681 | 7-3/4″ | In distribution |
| 3714184 | 5-3/8″ | In distribution |
| 3714017 | In distribution | |
| 3714450 | In distribution | |
| 3714032 | In distribution | |
| 3714684 | 8-1/2″ | In distribution |
| 3714179 | 4-3/8″ | 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.